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
FDA 510(k) clearance K201686 · decided 2020-09-17
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-22
- Decision date
- 2020-09-17
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICELTM POWDER Absorbable Hemostatic Powder (N12159/S129) | ETHICON, Inc. | 2026-07-28 |
| SURGICEL® Absorbable Hemostats (N12159/S130) | ETHICON, Inc. | 2026-06-25 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S070) | ETHICON, Inc. | 2026-06-25 |
| ETHIZIA Hemostatic Patch (P240035/S002) | ETHICON, Inc. | 2026-06-25 |
| ETHIZIA Hemostatic Patch (P240035/S005) | ETHICON, Inc. | 2026-02-26 |
| ETHIZIA Hemostatic Patch (P240035/S006) | ETHICON, Inc. | 2026-02-24 |
| ETHIZIA Hemostatic Patch (P240035/S003) | ETHICON, Inc. | 2026-01-28 |
| ETHIZIA Hemostatic Patch (P240035/S001) | ETHICON, Inc. | 2026-01-22 |