COAGULOOP

Electrode, Electrosurgical, Active, Urological

AMERICAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Coaguloop.

Pre-market Notification Details

Device IDK991314
510k NumberK991314
Device Name:COAGULOOP
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
ContactDavid Worrell
CorrespondentDavid Worrell
AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-16
Decision Date1999-06-29
Summary:summary

Trademark Results [COAGULOOP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COAGULOOP
COAGULOOP
75281821 2188559 Dead/Cancelled
American Medical Systems, Inc.
1997-04-28

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