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FDA 510(k)

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE

K-Number: K931518 · 1993-08-18

ApplicantImagyn Medical, Inc.
Decision Date1993-08-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical, Inc.. It received FDA 510(k) clearance on 1993-08-18 under 510(k) number K931518. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE?

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE is a medical device that received FDA 510(k) clearance on 1993-08-18. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K931518.

When did IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE receive FDA 510(k) clearance?

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE received FDA 510(k) clearance on 1993-08-18, under 510(k) number K931518.

Who is the listed applicant for IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE?

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

What is the FDA product code for IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE?

The FDA product code for IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE is GCJ.

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Other records listing Imagyn Medical, Inc. as applicant

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Related Devices (Code: GCJ)

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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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