FDA 510(k)

URETHRAL SUTURE GUIDE

K-Number: K950267 · 1995-01-31

Decision Date1995-01-31

Product CodeKOA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URETHRAL SUTURE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K950267. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETHRAL SUTURE GUIDE?

URETHRAL SUTURE GUIDE is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Applied Medical Resources. The 510(k) number is K950267.

When did URETHRAL SUTURE GUIDE receive FDA 510(k) clearance?

URETHRAL SUTURE GUIDE received FDA 510(k) clearance on 1995-01-31, under 510(k) number K950267.

Who is the listed applicant for URETHRAL SUTURE GUIDE?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URETHRAL SUTURE GUIDE?

The FDA product code for URETHRAL SUTURE GUIDE is KOA.

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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.