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FDA 510(k)

COOK-VPI CONTINENCE CUFF

K-Number: K863227 · 1987-02-03

ApplicantCook Urological, Inc.
Decision Date1987-02-03
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK-VPI CONTINENCE CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K863227. 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 COOK-VPI CONTINENCE CUFF?

COOK-VPI CONTINENCE CUFF is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Cook Urological, Inc.. The 510(k) number is K863227.

When did COOK-VPI CONTINENCE CUFF receive FDA 510(k) clearance?

COOK-VPI CONTINENCE CUFF received FDA 510(k) clearance on 1987-02-03, under 510(k) number K863227.

Who is the listed applicant for COOK-VPI CONTINENCE CUFF?

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

What is the FDA product code for COOK-VPI CONTINENCE CUFF?

The FDA product code for COOK-VPI CONTINENCE CUFF is FHA.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: FHA)

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K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.K964580CAP-AID (IMPROVED)Nebel, Inc.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, Inc.

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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