📋 FDA Reference
Nocc Hydrophilic Wound Dressing
Kytogenics
Summary: The nocc hydrophilic wound dressing by Kytogenics is a medical device used for wound management, particularly in cases requiring moisture retention and controlled drug release. It is commonly used by wound care specialists and in surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K080010 ↗
Decision Date ?
March 14, 2008
Product Code ?
KGN
Device Class ?
—
Evidence ?
419 studies
The nocc hydrophilic wound dressing was cleared via the FDA 510(k) pathway on March 14, 2008. Manufactured by Kytogenics, it is classified under product code KGN with no specific class designation.
What It Is
The nocc hydrophilic wound dressing is a specialized dressing designed to manage wounds by maintaining a moist environment conducive to healing. It incorporates N,O-carboxymethyl chitosan, a variant of chitosan known for its high degradation rate, allowing for immediate drug release. This dressing is particularly useful in delivering topical anti-infectives like mupirocin directly to the wound site.
FDA-Cleared Indications
- Management of wounds that benefit from a moist wound environment.
- Use as a hydrophilic wound dressing for wound care.
- Use with topical medication delivery when specified by the product labeling.
Clinical Applications
- Moist wound management in clinical wound-care settings.
- Coverage of wounds when maintaining moisture is part of the treatment plan.
- Use as part of a dressing regimen for wounds managed in hospitals, outpatient clinics, or specialized wound-care facilities.
Practical Considerations
- Select the dressing size and configuration that appropriately covers the wound without unnecessary overlap.
- Apply using the wound-care protocol and instructions supplied with the product; proper contact with the wound may be needed for the intended dressing function.
- The product may be used with other wound-care measures when clinically appropriate, but compatibility with topical drugs or secondary dressings should be confirmed before use.
- The supplied FDA record does not establish MRI labeling; review the current package labeling before MRI or other imaging.
- Use is subject to the product labeling and clinical assessment, including evaluation for infection, allergy or sensitivity to dressing materials, and wound characteristics.
Related Literature
The linked study investigated the development of a hybrid biomaterial ink using starch and N,O-carboxymethyl chitosan for 3D-printed wound dressings. The study found that varying the ratio of these components affects the degradation and drug release characteristics. Mupirocin was successfully incorporated into the biomaterial, demonstrating potential for controlled drug delivery. Limitations include the need for further clinical trials to validate efficacy in real-world settings.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is nocc hydrophilic wound dressing used for?
It is used for managing wounds that require moisture retention and controlled drug release, such as chronic wounds, surgical incisions, and burns.
What specialties typically use this device?
Wound care specialists, surgeons, and clinicians in both hospital and outpatient settings commonly use this device.
What are the FDA-cleared indications?
The device is indicated for managing wounds that benefit from a moist environment and controlled drug release, including chronic wounds and surgical sites.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.