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Pentax Os-A43H

by Hoya Corporation

Pentax Os-A43H is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K172156 on 5 Apr 2018 and listed in FDA GUDID since 31 Jul 2023 (UDI-DI 04961333075164), active as of 22 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 22 Oct 2026

Documents

510(k) K172156

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333075164 UDI-DI Date31 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172156 Date5 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172156 decided 5 Apr 2018 Active
  • FDA GUDID UDI-DI 04961333075164 listed 31 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172156
  2. Listed FDA GUDID 04961333075164

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pentax
Generic name
Endoscope calibration cover, reusable
Model / reference
OS-A43H
Primary DI / UDI-DI
04961333075164
FDA product code
EOB, PEA
GMDN term
Endoscope calibration cover, reusable
Device class
Class II
Regulation number
874.4760, 876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Endoscope calibration cover, reusable

Cleared under the same submission (K172156)

and 8 more cleared under K172156

Similar devices

Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

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