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FDA 510(k)

FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER

K-Number: K921120 · 1992-08-04

ApplicantCook Urological, Inc.
Decision Date1992-08-04
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER 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 1992-08-04 under 510(k) number K921120. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER?

FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER is a medical device that received FDA 510(k) clearance on 1992-08-04. The listed applicant is Cook Urological, Inc.. The 510(k) number is K921120.

When did FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER receive FDA 510(k) clearance?

FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER received FDA 510(k) clearance on 1992-08-04, under 510(k) number K921120.

Who is the listed applicant for FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER?

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 FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER?

The FDA product code for FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER is FED.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: FED)

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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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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