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FDA 510(k)

GM MONOPOLAR/FRAZIER SUCTION PROBE

K-Number: K934035 · 1993-12-01

ApplicantGm Engineering, Inc.
Decision Date1993-12-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GM MONOPOLAR/FRAZIER SUCTION 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 1993-12-01 under 510(k) number K934035. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM MONOPOLAR/FRAZIER SUCTION PROBE?

GM MONOPOLAR/FRAZIER SUCTION PROBE is a medical device that received FDA 510(k) clearance on 1993-12-01. The listed applicant is Gm Engineering, Inc.. The 510(k) number is K934035.

When did GM MONOPOLAR/FRAZIER SUCTION PROBE receive FDA 510(k) clearance?

GM MONOPOLAR/FRAZIER SUCTION PROBE received FDA 510(k) clearance on 1993-12-01, under 510(k) number K934035.

Who is the listed applicant for GM MONOPOLAR/FRAZIER SUCTION 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 MONOPOLAR/FRAZIER SUCTION PROBE?

The FDA product code for GM MONOPOLAR/FRAZIER SUCTION PROBE is GEI.

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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

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Related Devices (Code: GEI)

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.

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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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