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Clarus Endoscopy Pump 5169-100

by Clarus Medical, LLC

Clarus Endoscopy Pump 5169-100 is a Class II device made by Clarus Medical, LLC, cleared under FDA 510(k) K912447 on 27 Sep 1991 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI B06751691000), 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) K912447

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 NumberB06751691000 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK912447 Date27 Sep 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K912447 decided 27 Sep 1991 Active
  • FDA GUDID UDI-DI B06751691000 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K912447
  2. Listed FDA GUDID B06751691000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clarus Endoscopy Pump
Generic name
Endoscopic irrigation/aspiration pump
Model / Ref / Catalog
5169-100
Primary DI / UDI-DI
B06751691000
510(k) Number
FDA product code
FET
GMDN term
Endoscopic irrigation/aspiration pump
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology).

Other devices from Clarus Medical, LLC

See all devices from Clarus Medical, LLC →

Properties

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