K181151 is an FDA 510(k) clearance for the GYNECARE TVT Abbrevo Continence System. 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 August 10, 2018, 101 days after receiving the submission on May 1, 2018.
This device falls under the General & Plastic Surgery 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 | K181151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2018 |
| Decision Date | August 10, 2018 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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 |