GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
FDA 510(k) K173019 · ETHICON, Inc.
510(k) numberK173019
Submission
- Device name
- GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- September 28, 2017
- Decision date
- July 6, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PWJ – Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4910
- Specialty
- Obstetrics/Gynecology
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Other 510(k)s with product code PWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemPWJ · Traditional | ETHICON, Inc. | 08/10/2018SE |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE…PWJ · Traditional | ETHICON, Inc. | 06/28/2018SE |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator…PWJ · Traditional | Caldera Medical, Inc. | 05/04/2018SE |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…PWJ · Traditional | Boston Scientific Corporation | 12/20/2017SE |
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Questions and answers
When was GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar cleared by the FDA?
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar (K173019) received a 510(k) decision of Substantially Equivalent on July 6, 2018, 281 days after the submission was received.
What is the product code of K173019?
The FDA product code is PWJ – Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence, a Class II (moderate risk) device regulated under 21 CFR 884.4910.