K173162 is an FDA 510(k) clearance for the GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide. This device is classified as a Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (Class II - Special Controls, product code PWJ).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on June 28, 2018, 272 days after receiving the submission on September 29, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.4910. Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence.
| 510(k) Number | K173162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | June 28, 2018 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PWJ — Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4910 |
| Definition | Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence |