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 ID | K991314 |
| 510k Number | K991314 |
| Device Name: | COAGULOOP |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | David Worrell |
| Correspondent | David Worrell AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-06-29 |
| Summary: | summary |
Trademark Results [COAGULOOP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COAGULOOP 75281821 2188559 Dead/Cancelled |
American Medical Systems, Inc. 1997-04-28 |
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