FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProZip Knotless Implant
K Number: K253024
·
Decision Oct 16, 2025
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
27
Review Days
27
Basic Information
- Device Name
- ProZip Knotless Implant
- K Number
- K253024
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Riverpoint Medical
- Date Received
- September 19, 2025
- Decision Date
- October 16, 2025
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Riverpoint Medical
| K Number | Device Name | ||
|---|---|---|---|
| K252201 | HS Fiber | Aug 13, 2025 | Substantially Equivalent |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | Jul 30, 2025 | Substantially Equivalent |
| K243323 | Iconix Knotless Anchor | Nov 19, 2024 | Substantially Equivalent |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Oct 29, 2024 | Substantially Equivalent |
| K241282 | RibFix Titan Fixation System | Aug 19, 2024 | Substantially Equivalent |
| K241577 | Iconix® Anchor | Jul 3, 2024 | Substantially Equivalent |
| K240719 | OC JuggerKnot Soft Anchor | Apr 11, 2024 | Substantially Equivalent |
| K240213 | Iconix Knotless Anchor | Feb 23, 2024 | Substantially Equivalent |
| K240194 | ProCinch, QuadCinch | Feb 21, 2024 | Substantially Equivalent |
| K231163 | HS Fiber Sutures | Jan 5, 2024 | Substantially Equivalent |