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FDA 510(k)

GM SWIVEL VIDEO (TM) IRRIGATOR

K-Number: K931398 · 1993-08-30

ApplicantGm Engineering, Inc.
Decision Date1993-08-30
Product CodeKAR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GM SWIVEL VIDEO (TM) IRRIGATOR 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 1993-08-30 under 510(k) number K931398. The device is classified under product code KAR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM SWIVEL VIDEO (TM) IRRIGATOR?

GM SWIVEL VIDEO (TM) IRRIGATOR is a medical device that received FDA 510(k) clearance on 1993-08-30. The listed applicant is Gm Engineering, Inc.. The 510(k) number is K931398.

When did GM SWIVEL VIDEO (TM) IRRIGATOR receive FDA 510(k) clearance?

GM SWIVEL VIDEO (TM) IRRIGATOR received FDA 510(k) clearance on 1993-08-30, under 510(k) number K931398.

Who is the listed applicant for GM SWIVEL VIDEO (TM) IRRIGATOR?

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 SWIVEL VIDEO (TM) IRRIGATOR?

The FDA product code for GM SWIVEL VIDEO (TM) IRRIGATOR is KAR.

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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: KAR)

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.

K131177SINUFLUSH LAVAGE SYSTEMHedgepath, LLCK861298FISCH DRILL IRRIGATORJedmed Instrument Co.

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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