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FDA 510(k)

DILATING URETHRAL SOUND

K-Number: K933957 · 1993-11-17

ApplicantCook Urological, Inc.
Decision Date1993-11-17
Product CodeFAH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DILATING URETHRAL SOUND 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 1993-11-17 under 510(k) number K933957. The device is classified under product code FAH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILATING URETHRAL SOUND?

DILATING URETHRAL SOUND is a medical device that received FDA 510(k) clearance on 1993-11-17. The listed applicant is Cook Urological, Inc.. The 510(k) number is K933957.

When did DILATING URETHRAL SOUND receive FDA 510(k) clearance?

DILATING URETHRAL SOUND received FDA 510(k) clearance on 1993-11-17, under 510(k) number K933957.

Who is the listed applicant for DILATING URETHRAL SOUND?

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 DILATING URETHRAL SOUND?

The FDA product code for DILATING URETHRAL SOUND is FAH.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: FAH)

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.

K902370MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETERBoston Scientific CorpK902124DOWD CATHETERBoston Scientific CorpK831384COAXIAL BALLOON URETHRAL DILATORThomas J. Fogarty, M.D.

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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