UNICAPRONE
Device Facts
| Record ID | K072646 |
|---|---|
| Device Name | UNICAPRONE |
| Applicant | United Medical Industries Co. , Ltd. |
| Product Code | GAM · General, Plastic Surgery |
| Decision Date | Nov 7, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4493 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.
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.
