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FDA 510(k)

COAGULOOP

K-Number: K991314 · 1999-06-29

ApplicantAmerican Medical Systems, Inc.
Decision Date1999-06-29
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COAGULOOP 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 1999-06-29 under 510(k) number K991314. 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 COAGULOOP?

COAGULOOP is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K991314.

When did COAGULOOP receive FDA 510(k) clearance?

COAGULOOP received FDA 510(k) clearance on 1999-06-29, under 510(k) number K991314.

Who is the listed applicant for COAGULOOP?

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 COAGULOOP?

The FDA product code for COAGULOOP 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.

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