Polypropylene Nonabsorbable Surgical Sutures USP
FDA 510(k)Class II (US FDA 510(k))
by Cp Medical
Identifiers
- 510(k) Number
- K001185 FDA 510(k)
- FDA Product Code
- GAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5010 FDA 510(k)
- Regulation Number
- 878.5010 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SN FDA 510(k)
This device is a monofilament, nonabsorbable, sterile surgical suture composed of polypropylene polymer. It is classified as a Class I suture under USP monographs, designed for soft tissue approximation in surgical procedures. The material is flexible and intended for long-term wound support without degradation over time.
The sutures are supplied in sterile packaging for single-use applications in clinical settings. They are regulated under 21 CFR 878.5010 and hold an FDA 510(k) clearance (K001185) for use in general and plastic surgery. Available in various sizes and configurations, they require proper storage to maintain sterility and are not intended for reuse.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 21 CFR 878.5010 -- Nonabsorbable polypropylene surgical suture., USP Monographs: Nonabsorbable Surgical Suture - uspbpep.com, Polypropylene, Nonabsorbable Surgical Sutures Usp, Surgical Sutures - Performance Criteria for Safety and Performance ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001185 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cp Medical
Sources (1)
- FDA 510(k) K001185 24 fields · synced Oct 1, 2026