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Ambler Surgical

by Ambler Surgical, LLC 100 variants

Ambler Surgical (70-669) is a Class II device made by Ambler Surgical, LLC, cleared under FDA 510(k) K071771 on 2 Aug 2007 and listed in FDA GUDID since 7 Jan 2021 (UDI-DI 00190660213985), active as of 31 May 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 31 May 2026

Documents

510(k) K071771

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190660213985 UDI-DI Date7 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK071771 Date2 Aug 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071771 decided 2 Aug 2007 Active
  • FDA GUDID UDI-DI 00190660213985 listed 7 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K071771
  2. Listed FDA GUDID 00190660213985

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Upper-limb traction wrap/trap, reusable
Model / Ref / Catalog
Bookwalter-Style lateral vaginal retractor, 70-669
Primary DI / UDI-DI
00190660213985
510(k) Number
FDA product code
GZT
GMDN term
Upper-limb traction wrap/trap, reusable
Device class
Class II
Regulation number
882.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Upper-limb traction wrap/trap, reusable

Cleared under the same submission (K071771)

and 8 more cleared under K071771

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)