Ace-Tip Bipolar Forceps ACBF-016
Ace-Tip Bipolar Forceps ACBF-016 is a Class II device made by Cynosure, LLC, cleared under FDA 510(k) K964176 on 14 Aug 1997 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00841494103187), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841494103187 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK964176 | Date14 Aug 1997 | StatusActive |
Official records
- AccessGUDID record 00841494103187
- FDA 510(k) database K964176
Across registries
- FDA 510(k) K964176 decided 14 Aug 1997 Active
- FDA GUDID UDI-DI 00841494103187 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K964176
- Listed FDA GUDID 00841494103187
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ace-Tip Bipolar Forceps
- Generic name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Model / Ref / Catalog
- ACBF-016
- Description
- FORCEPS-NON-STICK 1.2MM, 7.0" , STRAIGHT
- Primary DI / UDI-DI
- 00841494103187
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution