ETHICON, Inc. · Class II · Cleared Sep 17, 2020
| K-number | K201686 |
| Device name | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide |
| Applicant | ETHICON, Inc. |
| Product code | OTN |
| Device class | Class II |
| Decision date | Sep 17, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
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