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FDA 510(k)

REPROCESSED GUIDEWIRES

K-Number: K012556 · 2002-04-29

ApplicantSterilmed, Inc.
Decision Date2002-04-29
Product CodeNML
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2002-04-29 under 510(k) number K012556. The device is classified under product code NML. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED GUIDEWIRES?

REPROCESSED GUIDEWIRES is a medical device that received FDA 510(k) clearance on 2002-04-29. The listed applicant is Sterilmed, Inc.. The 510(k) number is K012556.

When did REPROCESSED GUIDEWIRES receive FDA 510(k) clearance?

REPROCESSED GUIDEWIRES received FDA 510(k) clearance on 2002-04-29, under 510(k) number K012556.

Who is the listed applicant for REPROCESSED GUIDEWIRES?

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

What is the FDA product code for REPROCESSED GUIDEWIRES?

The FDA product code for REPROCESSED GUIDEWIRES is NML.

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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.

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