NWJ · Suture, Recombinant Technology
General, Plastic Surgery · 21 CFR 878.4494 · Class 2
Overview
| Product Code | NWJ |
|---|---|
| Device Name | Suture, Recombinant Technology |
| Regulation | 21 CFR 878.4494 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.
Classification Rationale
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).
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).
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211307 | GalaSTITCH Absorbable Monofilament Suture | Tepha, Inc. | May 27, 2021 | SESE |
| K132348 | TEPHAFLEX BRAIDED SUTURE | Tepha, Inc. | Sep 5, 2013 | SESE |
| K130422 | PHANTOM FIBER BIOFIBER SUTURE | Tornier, Inc. | Apr 4, 2013 | SESE |
| K122487 | BIOFIBER SYTURE | Tornier, Inc. | Sep 17, 2012 | SESE |
| K100876 | AESCULAP MONOMAX ABSORBABLE SUTURE | Aesculap, Inc. | Jul 14, 2010 | SESE |
| K082178 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | Oct 30, 2008 | SESE |
| K081099 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | Jul 15, 2008 | SESE |
| K072470 | BIOELAST 5-0 SUTURE, MODEL 500100 | Entrigue Surgical, Inc. | Nov 16, 2007 | SESE |
| DEN060003 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | Feb 8, 2007 | DENG |
Top Applicants
- Tepha, Inc. — 5 clearances
- Tornier, Inc. — 2 clearances
- Entrigue Surgical, Inc. — 1 clearance
- Aesculap, Inc. — 1 clearance
