Cushing Bayonet, Insulated Bipolar Forcep

Q: What is the product code of K974595?

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

FDA 510(k) K974595 · Titan Mfg., Inc.

Substantially Equivalent

510(k) numberK974595

Submission

Device name: Cushing Bayonet, Insulated 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)	Device	Applicant	Decision
K051281	The Needle CatcherHTD · Traditional	E.D.Medical , Ltd.	09/08/2005SE
K974594	Semkin Bipolar ForcepHTD · Traditional	Titan Mfg., Inc.	06/24/1998SE
K974593	Semkin Insulated Bipolar ForcepHTD · Traditional	Titan Mfg., Inc.	06/24/1998SE
K913964	Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional	Marlo Surgical Technology	10/23/1991SE
K911180	Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional	Northgate Technologies, Inc.	03/29/1991SE
K895212	Tik ExtraktorHTD · Traditional	Instruments of Sweden, Inc.	09/27/1989SE
K890373	Hemorrhoidal ForcepsHTD · Traditional	Kinetic Medical Products	02/03/1989SE
K890369	Gall Stone ForcepsHTD · Traditional	Kinetic Medical Products	02/03/1989SE
K890263	Cilia ForcepsHTD · Traditional	Kinetic Medical Products	01/27/1989SE
K890262	Lung ForcepsHTD · Traditional	Kinetic Medical Products	01/27/1989SE

More from Kinetic Medical Products

510(k)	Device	Decision
K974594	Semkin Bipolar ForcepHTD · Traditional	06/24/1998SE
K974593	Semkin Insulated Bipolar ForcepHTD · Traditional	06/24/1998SE

Questions and answers

When was Cushing Bayonet, Insulated Bipolar Forcep cleared by the FDA?

Cushing Bayonet, Insulated Bipolar Forcep (K974595) 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 K974595?

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