FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Polyform Synthetic Mesh
K Number: K171271
·
Decision Dec 15, 2017
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
22
Applicant Total
231
Review Days
228
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Polyform Synthetic Mesh
- K Number
- K171271
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- May 1, 2017
- Decision Date
- December 15, 2017
- Product Code
- OTO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTO), ordered by most recent decision date.
Vertessa Lite
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vertessa Lite Y-Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORELLE Y CONTOUR MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORELLE M, RESTORELLE XL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORELLE Y CONTOUR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Boston Scientific Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260428 | RIVOS EUS Access Device (M00553900) | Jun 17, 2026 | Substantially Equivalent |
| K260100 | MOSES Raydar | May 18, 2026 | Substantially Equivalent |
| K260771 | TruSelect 2.6 Microcatheter | May 15, 2026 | Substantially Equivalent |
| K251273 | Asurys Fluid Management System | Mar 27, 2026 | Substantially Equivalent |
| K260479 | TheraSphere 360 Y-90 Management Platform | Mar 13, 2026 | Substantially Equivalent |
| K260119 | SpaceOAR Vue System (SV-2101) | Feb 10, 2026 | Substantially Equivalent |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Oct 30, 2025 | Substantially Equivalent |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | Oct 30, 2025 | Substantially Equivalent |
| K252547 | TheraSphere 360 Y-90 Management Platform | Oct 28, 2025 | Substantially Equivalent |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Sep 26, 2025 | Substantially Equivalent |