Forceps

FDA 510(k) K771746 · Depuy, Inc.

Substantially Equivalent

510(k) numberK771746

Submission

Device name
Forceps
Applicant
Depuy, Inc.
Mchenry, IL, US
Received
September 15, 1977
Decision date
September 26, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GEN – Forceps, 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 GEN

510(k)DeviceApplicantDecision
K031828Naturalase LP Nd:Yag LaserGEN · Traditional Focus Medical, LLC07/17/2003SE
K953962ForcepsGEN · Traditional Biopsys Medical, Inc.09/08/1995SE
K932385Suture Removing ForcepsGEN · Traditional Rocket of London, Ltd.08/06/1993SE
K904723ForcepsGEN · Traditional Minto Research & Development, Inc.07/26/1991SE
K911159Palpation ProbeGEN · Traditional Northgate Technologies, Inc.03/29/1991SE
K900960GS-1500 Claw Forcep, 10MMGEN · Traditional Solos Endoscopy, Inc.04/18/1990SE
K900952GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional Solos Endoscopy, Inc.04/18/1990SE
K900951GS-7000 Clip-Applying Forcep, 10MM, Medium ClipGEN · Traditional Solos Endoscopy, Inc.04/18/1990SE
K900948GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional Solos Endoscopy, Inc.04/18/1990SE
K891896Tissue Forceps, Various TypesGEN · Traditional Zinnanti Surgical Instruments, Inc.04/12/1989SE

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Questions and answers

When was Forceps cleared by the FDA?

Forceps (K771746) received a 510(k) decision of Substantially Equivalent on September 26, 1977, 11 days after the submission was received.

What is the product code of K771746?

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