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FDA 510(k)

FORCEPS, BIOPSY, GASTROINTESTINAL

K-Number: K934186 · 1993-12-14

ApplicantPrimed Instruments, Inc.
Decision Date1993-12-14
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FORCEPS, BIOPSY, GASTROINTESTINAL is the device name listed in this FDA 510(k) record. The listed applicant is Primed Instruments, Inc.. It received FDA 510(k) clearance on 1993-12-14 under 510(k) number K934186. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORCEPS, BIOPSY, GASTROINTESTINAL?

FORCEPS, BIOPSY, GASTROINTESTINAL is a medical device that received FDA 510(k) clearance on 1993-12-14. The listed applicant is Primed Instruments, Inc.. The 510(k) number is K934186.

When did FORCEPS, BIOPSY, GASTROINTESTINAL receive FDA 510(k) clearance?

FORCEPS, BIOPSY, GASTROINTESTINAL received FDA 510(k) clearance on 1993-12-14, under 510(k) number K934186.

Who is the listed applicant for FORCEPS, BIOPSY, GASTROINTESTINAL?

The FDA 510(k) record lists Primed Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORCEPS, BIOPSY, GASTROINTESTINAL?

The FDA product code for FORCEPS, BIOPSY, GASTROINTESTINAL is FCL.

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Related Devices (Code: FCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.K964120INJECTO FLUSHRobert J. Jynch, Jr.K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.K955065OLYMPUS FB SERIES BIOPSY FORCEPSOlympus America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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