FDA 510(k)

UROLOGICAL CATHETER & ACCESSORIES

K-Number: K951178 · 1995-04-21

Decision Date1995-04-21

Product CodeFCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

UROLOGICAL CATHETER & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1995-04-21 under 510(k) number K951178. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROLOGICAL CATHETER & ACCESSORIES?

UROLOGICAL CATHETER & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-04-21. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K951178.

When did UROLOGICAL CATHETER & ACCESSORIES receive FDA 510(k) clearance?

UROLOGICAL CATHETER & ACCESSORIES received FDA 510(k) clearance on 1995-04-21, under 510(k) number K951178.

Who is the listed applicant for UROLOGICAL CATHETER & ACCESSORIES?

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

What is the FDA product code for UROLOGICAL CATHETER & ACCESSORIES?

The FDA product code for UROLOGICAL CATHETER & ACCESSORIES is FCM.

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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.