Disposable Bipolar Coagulating Forceps
by Kirwan Surgical Products, Inc.
510(k) K900533
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900533 | Date9 Apr 1990 | 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- Withdrawn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, 19 Sep 2026
The Disposable Bipolar Coagulating Forceps is a bipolar electrosurgical device designed for tissue coagulation and cutting. Classified under the product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), it delivers precise electrical energy to achieve hemostasis and controlled tissue separation in surgical procedures. Its bipolar configuration minimizes current dispersion, reducing the risk of unintended tissue damage.
Intended for single-use, these forceps are supplied sterile and require no reprocessing. They are intended for use in general and plastic surgery settings, adhering to FDA 510(k) clearance (K900533) under the Substantially Equivalent (SESE) determination. No specific MRI safety or storage conditions are noted in the regulatory data, though standard surgical instrument precautions apply.
Other devices from Kirwan Surgical Products LLC
Questions
AI-generated answers, 19 Sep 2026
Are these forceps reusable or designed for single-use only, and how does that affect their use in surgery?
These forceps are explicitly designed for single-use only and come sterile, eliminating the need for reprocessing. This design reduces the risk of cross-contamination and ensures consistent performance, which is critical in surgical settings where sterility and reliability are paramount.
What types of surgical procedures are these forceps intended for, and why is that classification important?
The forceps are classified under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories) and cleared for use in general and plastic surgery. This classification indicates their primary purpose is for tissue coagulation and cutting to achieve hemostasis and controlled separation, minimizing unintended tissue damage due to their bipolar configuration.
Do these forceps require any special storage conditions, or can they be kept with standard surgical instruments?
The regulatory data does not specify unique MRI safety or storage conditions beyond standard surgical instrument precautions. As long as they are stored in a clean, dry environment and protected from contamination, they can be kept with other sterile surgical instruments until use.
How do I know if these forceps are compatible with my electrosurgical unit, and what makes them different from monopolar devices?
These forceps are bipolar, meaning they deliver electrical energy between the two jaws of the forceps themselves, rather than relying on a grounding pad like monopolar devices. This design minimizes current dispersion, reducing the risk of unintended tissue damage and making them safer for precise coagulation and cutting in surgical procedures.