Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
FDA product code PWJ · 5 cleared devices
Class 2
Obstetrics/Gynecology
- Regulation
- 21 CFR 884.4910
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2017-12-20 – 2018-08-10
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
PWJ
2018-08-10
PWJ
2018-07-06
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
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PWJ
2018-06-28
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
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PWJ
2018-05-04
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
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PWJ
2017-12-20
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
View details →No matching devices.
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