FDA 510(k)

AMS COAGULOOP RESECTION ELECTRODE

K-Number: K971512 · 1997-07-24

Decision Date1997-07-24

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AMS COAGULOOP RESECTION ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K971512. 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 AMS COAGULOOP RESECTION ELECTRODE?

AMS COAGULOOP RESECTION ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K971512.

When did AMS COAGULOOP RESECTION ELECTRODE receive FDA 510(k) clearance?

AMS COAGULOOP RESECTION ELECTRODE received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971512.

Who is the listed applicant for AMS COAGULOOP RESECTION ELECTRODE?

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

What is the FDA product code for AMS COAGULOOP RESECTION ELECTRODE?

The FDA product code for AMS COAGULOOP RESECTION ELECTRODE is FAS.

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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.