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Ambler Surgical 75-542

by Ambler Surgical, LLC

Ambler Surgical 75-542 is a Class II device made by Ambler Surgical, LLC, cleared under FDA 510(k) K081651 on 8 Aug 2008 and listed in FDA GUDID since 29 Sep 2016 (UDI-DI 00190660147334), 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) K081651

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 Number00190660147334 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081651 Date8 Aug 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081651 decided 8 Aug 2008 Active
  • FDA GUDID UDI-DI 00190660147334 listed 29 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081651
  2. Listed FDA GUDID 00190660147334

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  • Withdrawn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
Spinal rongeur
Model / Ref / Catalog
75-542
Primary DI / UDI-DI
00190660147334
510(k) Number
FDA product code
HAE
GMDN term
Spinal rongeur
Device class
Class II
Regulation number
882.4840
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal rongeur

Cleared under the same submission (K081651)

and 8 more cleared under K081651

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)