FDA 510(k)

ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP

K-Number: K970526 · 1997-05-28

Decision Date1997-05-28

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 1997-05-28 under 510(k) number K970526. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP?

ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Arthrocare Corp.. The 510(k) number is K970526.

When did ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP receive FDA 510(k) clearance?

ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP received FDA 510(k) clearance on 1997-05-28, under 510(k) number K970526.

Who is the listed applicant for ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP?

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

What is the FDA product code for ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP?

The FDA product code for ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP is FAS.

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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.