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Gemini 7208329

by Smith & Nephew, Inc.

Gemini 7208329 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K914919 on 9 Jan 1992 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010430847), 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) K914919

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 Number03596010430847 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK914919 Date9 Jan 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K914919 decided 9 Jan 1992 Active
  • FDA GUDID UDI-DI 03596010430847 listed 30 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K914919
  2. Listed FDA GUDID 03596010430847

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gemini
Generic name
Endoscopic light source adaptor
Model / Ref / Catalog
7208329
Primary DI / UDI-DI
03596010430847
510(k) Number
FDA product code
GCJ
GMDN term
Endoscopic light source adaptor
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscopic light source adaptor

Cleared under the same submission (K914919)

and 8 more cleared under K914919

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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