510(k) K181151
- Device
- GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
- Applicant
- Ethicon Inc
- 510(k) number
- K181151
- Product code
- PWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-10
- Date received
- 2018-05-01
- Regulation
- 884.4910
- Classification name
- Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Debbie Fazen
- Address
- Rte. 22 W. Somerville NJ US 08876 08876
FDA Registration Numbers#
- 3021632375
- 3015924373
- 1828132
- 3003702646
- 1000121056
- 3005099803
- 2124215
- 3014272734
- 3003990090
Source Documents#
Other 510(k) Records For Product Code PWJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | ETHICON, Inc. | 2018-07-06 |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | ETHICON, Inc. | 2018-06-28 |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | Caldera Medical, Inc. | 2018-05-04 |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | Boston Scientific Corporation | 2017-12-20 |
Legacy Summary#
summary
FDA Review#
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