Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
The Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence is an obstetrics/gynecology device consisting of instruments used to aid in the insertion, placement, fixation, or anchoring of surgical mesh slings for the treatment of stress urinary incontinence, a condition characterized by involuntary urine leakage during physical exertion, coughing, or sneezing. It is classified as FDA Class II under regulation 21 CFR 884.4910, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PWJ, reviewed under the Gastroenterology/Urology panel. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWJ
- Device Class
- FDA class 2
- Regulation Number
- 884.4910
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | Aug 10, 2018 | Substantially Equivalent | ETHICON, Inc. |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | Jul 06, 2018 | Substantially Equivalent | ETHICON, Inc. |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | Jun 28, 2018 | Substantially Equivalent | ETHICON, Inc. |
| K172614 | 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 | May 04, 2018 | Substantially Equivalent | Caldera Medical, Inc. |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | Dec 20, 2017 | Substantially Equivalent | Boston Scientific Corporation |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.