📋 FDA Reference
Philips S1694 S1695
Philips Hearing Instruments
Summary: The Philips S1694 and S1695 are embolization liquid agents used to occlude blood vessels. They are typically used by interventional radiologists in procedures to treat vascular abnormalities.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K971804 ↗
Decision Date ?
June 6, 1997
Product Code ?
ESD
Device Class ?
Class 1
Evidence ?
419 studies
The Philips S1694 and S1695 were cleared through the FDA 510(k) pathway on June 6, 1997. Manufactured by Philips Hearing Instruments, these devices are classified as Class 1 under product code ESD.
What It Is
The Philips S1694 and S1695 are liquid agents used in embolization procedures. These devices work by being injected into the bloodstream to block blood flow to specific areas, such as tumors or arteriovenous malformations. They are designed to be biocompatible and effective in achieving vascular occlusion.
FDA-Cleared Indications
- Occlusion of blood vessels.
Clinical Applications
- Catheter-based embolization to intentionally block a selected blood vessel.
- Targeted vascular occlusion when reducing or stopping blood flow is clinically indicated.
Practical Considerations
- The available FDA record identifies the indication as vessel occlusion but does not provide enough detail here to confirm specific formulations, particle sizes, viscosities, or delivery specifications.
- Delivery generally requires selective catheterization and imaging guidance by a trained interventional specialist.
- Compatibility with a particular catheter, syringe, contrast mixture, or delivery system should be confirmed in the current product labeling and institutional protocol.
- Contraindications, precautions, preparation, and handling requirements depend on the specific formulation and should be checked in the official labeling.
- MRI safety cannot be determined from the information provided; review the current labeling or contact the manufacturer before MRI.
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 Philips S1694 S1695 used for?
These devices are used for embolization to occlude blood vessels in conditions such as tumors or arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists primarily use these devices in procedures requiring vascular occlusion.
What are the FDA-cleared indications?
The devices are indicated for the occlusion of blood vessels, useful in treating vascular abnormalities and tumors.
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.