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FDA 510(k)

GM CONTINUOUS FLOW BIOPSY PROBE

K-Number: K933962 · 1994-02-25

ApplicantGm Engineering, Inc.
Decision Date1994-02-25
Product CodeFDC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GM CONTINUOUS FLOW BIOPSY PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Gm Engineering, Inc.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K933962. The device is classified under product code FDC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM CONTINUOUS FLOW BIOPSY PROBE?

GM CONTINUOUS FLOW BIOPSY PROBE is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Gm Engineering, Inc.. The 510(k) number is K933962.

When did GM CONTINUOUS FLOW BIOPSY PROBE receive FDA 510(k) clearance?

GM CONTINUOUS FLOW BIOPSY PROBE received FDA 510(k) clearance on 1994-02-25, under 510(k) number K933962.

Who is the listed applicant for GM CONTINUOUS FLOW BIOPSY PROBE?

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

What is the FDA product code for GM CONTINUOUS FLOW BIOPSY PROBE?

The FDA product code for GM CONTINUOUS FLOW BIOPSY PROBE is FDC.

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Other records listing Gm Engineering, 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.

K953348ARTICULATING RETRACTOR TISSUE RETRACTORSK942626CONTINUOUS FLOW BIOPSY PROBEK932394BERNSTEIN(TM) UTERINE MANIPULATORK941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTK942703GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULAK941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT

View all 11 devices →

Related Devices (Code: FDC)

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.

K021166ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BRAcmi-Circon CorporationK992141OLYMPUS WORKING ELEMENT FOR PROBESOlympus Winter & Ibe GmbHK991426MAHE INSTRUMENTSMahe Intl., Inc.K942626CONTINUOUS FLOW BIOPSY PROBEGm Engineering, Inc.K895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, Inc.K894363UROPUMP* FLUID MANAGEMENT SYSTEMOrthoconcept, 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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