Semkin Bipolar Forcep

FDA 510(k) K974594 · Titan Mfg., Inc.

Substantially Equivalent

510(k) numberK974594

Submission

Device name
Semkin Bipolar Forcep
Applicant
Titan Mfg., Inc.
Phoenixville, PA, US
Received
December 9, 1997
Decision date
June 24, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HTD – Forceps
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code HTD

510(k)DeviceApplicantDecision
K051281The Needle CatcherHTD · Traditional E.D.Medical , Ltd.09/08/2005SE
K974595Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K974593Semkin Insulated Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K913964Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional Marlo Surgical Technology10/23/1991SE
K911180Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional Northgate Technologies, Inc.03/29/1991SE
K895212Tik ExtraktorHTD · Traditional Instruments of Sweden, Inc.09/27/1989SE
K890373Hemorrhoidal ForcepsHTD · Traditional Kinetic Medical Products02/03/1989SE
K890369Gall Stone ForcepsHTD · Traditional Kinetic Medical Products02/03/1989SE
K890263Cilia ForcepsHTD · Traditional Kinetic Medical Products01/27/1989SE
K890262Lung ForcepsHTD · Traditional Kinetic Medical Products01/27/1989SE

More from Kinetic Medical Products

510(k)DeviceDecision
K974595Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional 06/24/1998SE
K974593Semkin Insulated Bipolar ForcepHTD · Traditional 06/24/1998SE

Questions and answers

When was Semkin Bipolar Forcep cleared by the FDA?

Semkin Bipolar Forcep (K974594) received a 510(k) decision of Substantially Equivalent on June 24, 1998, 197 days after the submission was received.

What is the product code of K974594?

The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.