FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K Number: K211223
·
Decision Jul 21, 2021
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
231
Review Days
89
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Basic Information
- Device Name
- Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K Number
- K211223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- April 23, 2021
- Decision Date
- July 21, 2021
- Product Code
- OTN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTN), ordered by most recent decision date.
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
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Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
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GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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