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Ace-Tip Bipolar Forceps ACBF-012

by Cynosure, LLC

Ace-Tip Bipolar Forceps ACBF-012 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 00841494103125), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K964176

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841494103125 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK964176 Date14 Aug 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K964176 decided 14 Aug 1997 Active
  • FDA GUDID UDI-DI 00841494103125 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K964176
  2. Listed FDA GUDID 00841494103125

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ace-Tip Bipolar Forceps
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Model / Ref / Catalog
ACBF-012
Description
FORCEPS-NON-STICK 0.5MM, 4.5" , STRAIGHT
Primary DI / UDI-DI
00841494103125
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

Related devices

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Cleared under the same submission (K964176)

and 8 more cleared under K964176

Similar devices in this category

Other devices filed under Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.

Other devices from Cynosure, LLC

See all devices from Cynosure, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)