FDA 510(k)

UROLOGICAL GUIDWIRE

K-Number: K944135 · 1994-09-21

Decision Date1994-09-21

Product CodeKNY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

UROLOGICAL GUIDWIRE 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 1994-09-21 under 510(k) number K944135. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROLOGICAL GUIDWIRE?

UROLOGICAL GUIDWIRE is a medical device that received FDA 510(k) clearance on 1994-09-21. The listed applicant is Applied Medical Resources. The 510(k) number is K944135.

When did UROLOGICAL GUIDWIRE receive FDA 510(k) clearance?

UROLOGICAL GUIDWIRE received FDA 510(k) clearance on 1994-09-21, under 510(k) number K944135.

Who is the listed applicant for UROLOGICAL GUIDWIRE?

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 UROLOGICAL GUIDWIRE?

The FDA product code for UROLOGICAL GUIDWIRE is KNY.

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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.