ORTHOPEDIC PACKS
Device Facts
| Record ID | K951231 |
|---|---|
| Device Name | ORTHOPEDIC PACKS |
| Applicant | Sterile Concepts, Inc. |
| Product Code | GAN · General, Plastic Surgery |
| Decision Date | Dec 1, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4830 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.
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.
