Decision Date1995-08-02
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
IMAGYN UROSCOPE 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 1995-08-02 under 510(k) number K953201. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IMAGYN UROSCOPE?
IMAGYN UROSCOPE is a medical device that received FDA 510(k) clearance on 1995-08-02. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K953201.
When did IMAGYN UROSCOPE receive FDA 510(k) clearance?
IMAGYN UROSCOPE received FDA 510(k) clearance on 1995-08-02, under 510(k) number K953201.
Who is the listed applicant for IMAGYN UROSCOPE?
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 UROSCOPE?
The FDA product code for IMAGYN UROSCOPE is FAJ.
Related Clinical Trials
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Other records listing Imagyn Medical, 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.
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Related Devices (Code: FAJ)
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Official Source
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