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Unitips Surgical Instruments
Unisurge
Summary: Unitips surgical instruments by Unisurge are FDA-cleared devices used in various surgical procedures. Key evidence highlights their historical significance and quality control issues.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K925882 ↗
Decision Date ?
August 10, 1993
Product Code ?
GCJ
Device Class ?
Class 2
Evidence ?
0 studies
Unitips surgical instruments received FDA clearance through the 510(k) pathway on August 10, 1993. Manufactured by Unisurge, they are classified as Class 2 devices under product code GCJ.
What It Is
Unitips surgical instruments are a range of tools designed for use in surgical procedures, particularly involving the portal vein. They are intended to aid surgeons in performing precise and effective operations.
FDA-Cleared Indications
- For use as surgical instruments during procedures involving the portal vein.
- For use by qualified healthcare professionals in surgical procedures consistent with the device labeling.
Clinical Applications
- Surgical procedures involving the portal vein
- General surgical handling and manipulation of tissue or vessels when consistent with the labeled instrument design
- Use by surgeons as part of an operative set during vascular or abdominal surgery, when included in the device labeling
Evidence Summary
The available literature includes 10 studies ranging from 1997 to 2024, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies provide insights into the historical and practical aspects of surgical instruments.
Reported Outcomes
Published studies report on the historical significance and quality of surgical instruments, noting issues such as scissors that do not cut effectively and artery clips that fail in difficult locations. The evidence highlights the importance of quality control in surgical tools.
Safety Profile
Reported complications include quality issues with new instruments, such as ineffective cutting and unreliable clips, which can impact surgical outcomes. These findings underscore the need for rigorous quality assurance processes.
Evidence Limitations
The evidence is limited by a lack of specific outcome data and detailed safety profiles. Further research is needed to evaluate the efficacy and safety of these instruments in contemporary surgical practice.
Practical Considerations
- The available FDA record does not identify the individual instruments, sizes, materials, or specific functions included in the Unitips product range; confirm these details in the current manufacturer instructions.
- Use only instruments appropriate for the intended tissue, vessel, and surgical technique, and confirm compatibility with related surgical equipment before use.
- Reusable instruments require cleaning, inspection, sterilization, and maintenance according to the manufacturer’s instructions and institutional policy.
- MRI safety cannot be determined from the available record. Do not bring the instruments into an MRI environment unless their labeling identifies them as MR Safe or MR Conditional.
- The FDA record does not list patient-specific contraindications; contraindications and precautions should be determined from the current labeling and the planned surgical procedure.
Frequently Asked Questions
What are the clinical indications for Unitips surgical instruments?
Unitips surgical instruments are indicated for use in surgeries involving the portal vein and related procedures.
What outcomes have been reported in clinical studies?
Studies report historical significance and quality control issues, highlighting the need for reliable surgical tools.
What complications have been reported?
Safety data indicate issues with instrument quality, such as ineffective cutting and unreliable clips.
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.