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FDA 510(k)

MODULAR BIOPSY FORCEP

K-Number: K946360 · 1995-03-06

ApplicantCox Medical Ent., Inc.
Decision Date1995-03-06
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODULAR BIOPSY FORCEP is the device name listed in this FDA 510(k) record. The listed applicant is Cox Medical Ent., Inc.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K946360. 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 MODULAR BIOPSY FORCEP?

MODULAR BIOPSY FORCEP is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Cox Medical Ent., Inc.. The 510(k) number is K946360.

When did MODULAR BIOPSY FORCEP receive FDA 510(k) clearance?

MODULAR BIOPSY FORCEP received FDA 510(k) clearance on 1995-03-06, under 510(k) number K946360.

Who is the listed applicant for MODULAR BIOPSY FORCEP?

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

What is the FDA product code for MODULAR BIOPSY FORCEP?

The FDA product code for MODULAR BIOPSY FORCEP is FCL.

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Other records listing Cox Medical Ent., Inc. as applicant

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.

K950689UCBK941464BASICS ENDOSCOPY SYSTEMK940911BASICS ENDOSCOPY SYSTEMK932790THERMAL OPTIONK935250ACCU-PATHK924655COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)

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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

View on FDA Database →

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

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