Forceps, Biopsy, Gastrointestinal

FDA 510(k) K934186 · Primed Instruments, Inc.

Substantially Equivalent

510(k) numberK934186

Submission

Device name
Forceps, Biopsy, Gastrointestinal
Applicant
Primed Instruments, Inc.
M9c 4h3, CA
Received
August 26, 1993
Decision date
December 14, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FCL – Forceps, Biopsy, Non-Electric
Device class
Class I (low risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCL

510(k)DeviceApplicantDecision
K032092Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional Olympus Optical Co., Ltd.07/16/2003SE
K973611Spectrascience Reusable Biopsy ForcepsFCL · Traditional Spectrascience, Inc.12/02/1997SE
K971315Auxiliary Instruments for UrsFCL · Traditional Richard Wolf Medical Instruments Corp.09/15/1997SE
K964120Injecto FlushFCL · Traditional Robert J. Jynch, Jr.12/30/1996SE
K963517Spectra Science Biopsy ForcepsFCL · Traditional Spectrascience, Inc.12/02/1996SE
K955065Olympus FB Series Biopsy ForcepsFCL · Traditional Olympus America, Inc.01/24/1996SE
K952863Forceps, Biopsy, Non-ElectricFCL · Traditional Annex Medical, Inc.07/19/1995SE
K952391Dynabite Urological ForcepsFCL · Traditional Portlyn Corp.06/01/1995SE
K951048Rite-Bite Biopsy ForcepsFCL · Traditional Mill-Rose Laboratory03/15/1995SE
K946360Modular Biopsy ForcepFCL · Traditional Cox Medical Ent., Inc.03/06/1995SE

Questions and answers

When was Forceps, Biopsy, Gastrointestinal cleared by the FDA?

Forceps, Biopsy, Gastrointestinal (K934186) received a 510(k) decision of Substantially Equivalent on December 14, 1993, 110 days after the submission was received.

What is the product code of K934186?

The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.