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Lens 72204354S

by Smith & Nephew, Inc.

Lens 72204354S is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K153606 on 2 Jun 2016 and listed in FDA GUDID since 15 Aug 2017 (UDI-DI 00885556632000), 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) K153606

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 Number00885556632000 UDI-DI Date15 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153606 Date2 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153606 decided 2 Jun 2016 Active
  • FDA GUDID UDI-DI 00885556632000 listed 15 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153606
  2. Listed FDA GUDID 00885556632000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lens
Generic name
Endoscopic video imaging system
Model / Ref / Catalog
72204354S
Description
SERVICE REPLACEMENT LENS INTEGRATED SYSTEM WIFI VERSION
Primary DI / UDI-DI
00885556632000
510(k) Number
FDA product code
GCJ
GMDN term
Endoscopic video imaging system
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, general & plastic surgery).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)