The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Coaguloop Resection Electrode.
| Device ID | K971512 |
| 510k Number | K971512 |
| Device Name: | AMS COAGULOOP RESECTION ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | John M Otto |
| Correspondent | John M Otto 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 | 1997-04-28 |
| Decision Date | 1997-07-24 |
| Summary: | summary |