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Single Use Kit GS002

by Gyder Surgical Pty Ltd

Single Use Kit GS002 is a Class II device made by Gyder Surgical Pty Ltd, cleared under FDA 510(k) K243387 on 29 Jan 2025 and listed in FDA GUDID since 18 Sep 2025 (UDI-DI 09360506000029), 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) K243387

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 Number09360506000029 UDI-DI Date18 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243387 Date29 Jan 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243387 decided 29 Jan 2025 Active
  • FDA GUDID UDI-DI 09360506000029 listed 18 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243387
  2. Listed FDA GUDID 09360506000029

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Single Use Kit
Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / reference
GS002
Primary DI / UDI-DI
09360506000029
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K243387)

Other devices from Gyder Surgical Pty Ltd

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)