TEPHAFLEX ABSORBABLE SUTURE
Device Facts
| Record ID | DEN060003 |
|---|---|
| Device Name | TEPHAFLEX ABSORBABLE SUTURE |
| Applicant | Tepha, Inc. |
| Product Code | NWJ · General, Plastic Surgery |
| Decision Date | Feb 8, 2007 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 878.4494 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).
