FDA 510(k)

SUBCUTANEOUS URINARY DIVERSON STENT SET

K-Number: K961371 · 1996-07-24

Decision Date1996-07-24

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SUBCUTANEOUS URINARY DIVERSON STENT SET 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 1996-07-24 under 510(k) number K961371. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUBCUTANEOUS URINARY DIVERSON STENT SET?

SUBCUTANEOUS URINARY DIVERSON STENT SET is a medical device that received FDA 510(k) clearance on 1996-07-24. The listed applicant is Cook Urological, Inc.. The 510(k) number is K961371.

When did SUBCUTANEOUS URINARY DIVERSON STENT SET receive FDA 510(k) clearance?

SUBCUTANEOUS URINARY DIVERSON STENT SET received FDA 510(k) clearance on 1996-07-24, under 510(k) number K961371.

Who is the listed applicant for SUBCUTANEOUS URINARY DIVERSON STENT SET?

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 SUBCUTANEOUS URINARY DIVERSON STENT SET?

The FDA product code for SUBCUTANEOUS URINARY DIVERSON STENT SET is FAD.

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Related Devices (Code: FAD)

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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.