510(k) K181151
K181151 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System". The FDA issued a decision of Substantially Equivalent on August 10, 2018. The device falls under product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence), a Class II device regulated under 21 CFR 884.4910. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2018
- Date Received
- May 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 884.4910
- Review Panel
- GU
- Submission Type
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence