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gSource gS 78.2840

by Gsource, LLC.

gSource gS 78.2840 is a Class II device made by Gsource, LLC., cleared under FDA 510(k) K100736 on 10 Sep 2010 and listed in FDA GUDID since 31 Mar 2017 (UDI-DI M7557828401), 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) K100736

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 NumberM7557828401 UDI-DI Date31 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100736 Date10 Sep 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100736 decided 10 Sep 2010 Active
  • FDA GUDID UDI-DI M7557828401 listed 31 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100736
  2. Listed FDA GUDID M7557828401

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
gSource
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
gS 78.2840
Primary DI / UDI-DI
M7557828401
510(k) Number
FDA product code
JDW
GMDN term
Orthopaedic bone wire
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K100736)

and 8 more cleared under K100736

Other devices from Gsource, LLC.

See all devices from Gsource, LLC. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)