Valleylab Macrobipolar Forceps Handpiece, E3200
by Valleylab, Inc. 510(k)
Active
510(k) K926414
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926414 | Date17 May 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 Valleylab Macrobipolar Forceps Handpiece, E3200, is an electrosurgical device classified under Electrosurgical, Cutting & Coagulation & Accessories. It is designed for precise bipolar electrosurgical applications, delivering controlled tissue coagulation and cutting with minimal thermal spread to surrounding tissues. This handpiece integrates with macrobipolar generators to enhance surgical precision in procedures requiring fine manipulation and energy delivery.
Intended for use in surgical settings, the E3200 is a reusable device, requiring proper sterilisation between procedures. It is compatible with MRI environments, as indicated by its classification, and is supplied as part of a larger electrosurgical system. Authorised under FDA 510(k) clearance (K926414), this handpiece adheres to regulatory standards for electrosurgical accessories, ensuring safety and performance in general and plastic surgery applications.