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Ambler Surgical Babcock grasping forceps

by Ambler Surgical, LLC 6 variants

Ambler Surgical Babcock grasping forceps (97-034) is a Class II device made by Ambler Surgical, LLC, cleared under FDA 510(k) K040855 on 16 Apr 2004 and listed in FDA GUDID since 4 Jan 2021 (UDI-DI 00190660040055), active as of 23 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 23 Oct 2026

Documents

510(k) K040855

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190660040055 UDI-DI Date4 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040855 Date16 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040855 decided 16 Apr 2004 Active
  • FDA GUDID UDI-DI 00190660040055 listed 4 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040855
  2. Listed FDA GUDID 00190660040055

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ambler Surgical
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Model / Ref / Catalog
Babcock grasping forceps, 97-034
Primary DI / UDI-DI
00190660040055
510(k) Number
FDA product code
GEI
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid endoscopic tissue manipulation forceps, reusable

Cleared under the same submission (K040855)

and 8 more cleared under K040855

Similar devices in this category

Other devices filed under Rigid endoscopic tissue manipulation forceps, reusable.

Other devices from Ambler Surgical, LLC

See all devices from Ambler Surgical, LLC →

Properties

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