FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
K Number: K172565
·
Decision Dec 20, 2017
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
4
Applicant Total
193
Review Days
117
Basic Information
- 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
- K Number
- K172565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4910
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- August 25, 2017
- Decision Date
- December 20, 2017
- Product Code
- PWJ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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FDA 510(k)
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GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
FDA 510(k)
FDA Class 2
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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
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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