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FDA 510(k)

MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE

K-Number: K970308 · 1997-04-02

ApplicantMentor Urology, Inc.
Decision Date1997-04-02
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Urology, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K970308. The device is classified under product code FHA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE?

MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Mentor Urology, Inc.. The 510(k) number is K970308.

When did MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE receive FDA 510(k) clearance?

MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970308.

Who is the listed applicant for MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE?

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

What is the FDA product code for MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE?

The FDA product code for MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE is FHA.

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Related Devices (Code: FHA)

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.

K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.K964580CAP-AID (IMPROVED)Nebel, Inc.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, Inc.K952841THE ASSISTANTApple Medical Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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