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Suction/Irrigation Kittner

by O.R. Concepts, Inc. 510(k)

Active United States

510(k) K914781

Overview

Suction/Irrigation Kittner is a device used for suction and irrigation procedures. It is classified under product code GCJ for General & Plastic Surgery.

It is supplied as a reusable device and was cleared through the FDA 510(k) Traditional pathway under K914781 on December 9, 1991. The device is manufactured by O.R. Concepts, Inc. and is intended for use in clinical settings requiring suction and irrigation functionality.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914781 Date9 Dec 1991ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from O.R. Concepts, Inc.

See all devices from O.R. Concepts, Inc. →

Questions

  • What is the Suction/Irrigation Kittner used for?

    The Suction/Irrigation Kittner is used for suction and irrigation procedures in clinical settings, particularly in general and plastic surgery, as indicated by its product code GCJ classification.

  • Is the Suction/Irrigation Kittner a reusable or single-use device?

    The Suction/Irrigation Kittner is supplied as a reusable device, meaning it is designed to be cleaned, sterilized, and used multiple times in accordance with manufacturer instructions and institutional reprocessing protocols.

  • How was the Suction/Irrigation Kittner cleared for market release?

    The Suction/Irrigation Kittner was cleared through the FDA 510(k) Traditional pathway under submission number K914781, with a decision date of December 9, 1991, based on a finding of substantial equivalence to a predicate device.