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7153-02

by PENTAX of America Inc.

7153-02 is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K093792 on 18 Mar 2010 and listed in FDA GUDID since 26 Jun 2017 (UDI-DI 04961333233977), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K093792

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333233977 UDI-DI Date26 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093792 Date18 Mar 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093792 decided 18 Mar 2010 Active
  • FDA GUDID UDI-DI 04961333233977 listed 26 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093792
  2. Listed FDA GUDID 04961333233977

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Endoscopic light source unit, line-powered
Model / reference
7153-02
Primary DI / UDI-DI
04961333233977
510(k) Number
FDA product code
FCW
GMDN term
Endoscopic light source unit, line-powered
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic light source unit, line-powered

Cleared under the same submission (K093792)

Similar devices in this category

Other devices filed under Endoscopic light source unit, line-powered.

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

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