Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
FDA 510(k) K172565 · Boston Scientific Corporation
510(k) numberK172565
Submission
- Device name
- Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- August 25, 2017
- Decision date
- December 20, 2017
- 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 |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE…PWJ · Traditional | ETHICON, Inc. | 07/06/2018SE |
| 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 |
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Questions and answers
When was Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device cleared by the FDA?
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (K172565) received a 510(k) decision of Substantially Equivalent on December 20, 2017, 117 days after the submission was received.
What is the product code of K172565?
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.