MXW · Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
General, Plastic Surgery · 21 CFR 878.5010 · Class 2
Overview
| Product Code | MXW |
|---|---|
| Device Name | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) |
| Regulation | 21 CFR 878.5010 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060465 | PREMIO | Peters Surgical | Jan 17, 2007 | SESE |
| K052953 | NUVANCE* FACIAL REJUVENATION SYSTEM | ETHICON, Inc. | Mar 6, 2006 | SESE |
Top Applicants
- ETHICON, Inc. — 1 clearance
- Peters Surgical — 1 clearance
