Klein Micro-Cannula Handle(Tm)

FDA 510(k) K901719 · Jeff Klein Surgical, Inc.

Substantially Equivalent

510(k) numberK901719

Submission

Device name
Klein Micro-Cannula Handle(Tm)
Applicant
Jeff Klein Surgical, Inc.
San Clemente, CA, US
Received
April 13, 1990
Decision date
May 22, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GEA – Cannula, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GEA

510(k)DeviceApplicantDecision
K003965MRI Safe InstrumentsGEA · Traditional Aesculap, Inc.03/16/2001SE
K982472Genicon TrocarGEA · Traditional Genicon, LC02/04/1999SE
K954599Conmed Trogard Electronic Trocar SystemGEA · Traditional Conmedcorp11/27/1995SE
K922460Origin Secondary Cannula and TrocarGEA · Traditional Origin Medsystems, Inc.09/16/1992SE
K920110Endopath Disposable Thoracic Trocar SleeveGEA · Traditional ETHICON, Inc.04/02/1992SE
K911262Disposable Specimen Bag W/Cannula and IntroducerGEA · Traditional ETHICON, Inc.06/20/1991SE
K904881Disposable Yankauer Suction TubeGEA · Traditional Pilling Medical S.A.03/06/1991SE
K903416Cannula, SurgicalGEA · Traditional Advantage Diagnostics Corp.11/23/1990SE
K904218Suction SystemGEA · Traditional Axiom Medical, Inc.10/31/1990SE
K901718Klein Lamprey-Cannula(Tm)GEA · Traditional Jeff Klein Surgical, Inc.05/24/1990SE

More from Jeff Klein Surgical, Inc.

510(k)DeviceDecision
K901718Klein Lamprey-Cannula(Tm)GEA · Traditional 05/24/1990SE
K901717Klein Micro-Cannula(Tm)GEA · Traditional 05/24/1990SE
K901716Klein Connector(Tm)GCE · Traditional 05/11/1990SE
K901715Klein Cork(Tm)GCE · Traditional 05/11/1990SE

Questions and answers

When was Klein Micro-Cannula Handle(Tm) cleared by the FDA?

Klein Micro-Cannula Handle(Tm) (K901719) received a 510(k) decision of Substantially Equivalent on May 22, 1990, 39 days after the submission was received.

What is the product code of K901719?

The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.