Surgi-Link Bipolar Micro Forceps
by Unimed Surgical Products, Inc.
510(k) K946246
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946246 | Date7 Mar 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Surgi-Link Bipolar Micro Forceps is a bipolar electrosurgical instrument designed for precise tissue coagulation and dissection. It features micro-tip configurations ranging from 0.3 mm to 2.0 mm, enabling fine control in delicate surgical procedures. This device is classified under product code GEI, aligning with general plastic surgery applications. Its bipolar design minimizes heat dispersion, reducing collateral tissue damage during use.
These forceps are supplied as reusable surgical instruments, intended for use in operating rooms and procedural settings requiring electrosurgical precision. They are available in multiple tip sizes to accommodate varying clinical needs, with a flat, bayonet-style handle to maintain surgical field visibility. The device holds an FDA 510(k) clearance (K946246) under the Traditional pathway, with a decision date of March 7, 1995. No specific sterility or MRI safety information is provided in the available data.
Other devices from Unimed Surgical Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Surgi-Link Bipolar Micro Forceps used for?
The Surgi-Link Bipolar Micro Forceps is designed for precise tissue coagulation and dissection in surgical procedures. Its bipolar design ensures targeted heat application, reducing heat dispersion and minimizing damage to surrounding tissues. This makes it particularly useful in delicate operations where fine control is required, such as in general plastic surgery applications.
Are the Surgi-Link Bipolar Micro Forceps reusable or single-use?
The Surgi-Link Bipolar Micro Forceps are supplied as reusable surgical instruments. They are intended for repeated use in operating rooms and procedural settings, provided they are properly cleaned, sterilized, and maintained between uses. This design aligns with clinical practices where reusable tools are preferred for cost-effectiveness and reliability.
What tip sizes are available for the Surgi-Link Bipolar Micro Forceps?
The device offers micro-tip configurations ranging from 0.3 mm to 2.0 mm. These varied tip sizes allow clinicians to select the appropriate tool for specific surgical tasks, ensuring adaptability to different tissue types and procedural requirements. The range supports precision in both fine and slightly larger-scale dissections.
How is the Surgi-Link Bipolar Micro Forceps supplied, and what does the handle design provide?
The forceps are supplied as reusable instruments, typically packaged for sterilization and clinical use. The handle features a flat, bayonet-style design, which enhances visibility in the surgical field by reducing obstruction. This design choice prioritizes the surgeon’s ability to maintain clear sight of the operative area while manipulating the tool.
Is there any information provided about sterility or MRI safety for the Surgi-Link Bipolar Micro Forceps?
The available data does not specify details regarding sterility protocols or MRI safety for the Surgi-Link Bipolar Micro Forceps. Clinicians should follow standard sterilization practices for reusable surgical instruments and consult manufacturer guidelines or MRI safety databases for compatibility information before use in MRI environments.