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Lens 72203967

by Smith & Nephew, Inc.

Lens 72203967 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 10 Jun 2016 (UDI-DI 00885556629833), 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 Number00885556629833 UDI-DI Date10 Jun 2016ListedStatusListed 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 00885556629833 listed 10 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153606
  2. Listed FDA GUDID 00885556629833

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  • Withdrawn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
72203967
Primary DI / UDI-DI
00885556629833
510(k) Number
FDA product code
HRX, GCJ
GMDN term
Endoscopic video imaging system
Device class
Class II
Regulation number
888.1100, 876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Liquid Chemical

Related devices

Category: Endoscopic video imaging system

Cleared under the same submission (K153606)

and 8 more cleared under K153606

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)