GAN · Suture, Absorbable, Synthetic
General, Plastic Surgery · 21 CFR 878.4830 · Class 2
Overview
| Product Code | GAN |
|---|---|
| Device Name | Suture, Absorbable, Synthetic |
| Regulation | 21 CFR 878.4830 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.
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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | Surgical Specialties Corp | Dec 15, 2000 | SESE |
| K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | ETHICON, Inc. | Dec 18, 1996 | SESE |
| K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | ETHICON, Inc. | Mar 28, 1996 | SESE |
| K951231 | ORTHOPEDIC PACKS | Sterile Concepts, Inc. | Dec 1, 1995 | SESE |
| K920978 | ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED | ETHICON, Inc. | Feb 15, 1994 | SESE |
| K900198 | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | American Cyanamid Co. | Jul 5, 1990 | SN |
| K895579 | POLYSORB SYNTHETIC ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | Jul 5, 1990 | SN |
Top Applicants
- ETHICON, Inc. — 3 clearances
- American Cyanamid Co. — 1 clearance
- Sterile Concepts, Inc. — 1 clearance
- Surgical Specialties Corp — 1 clearance
- United States Surgical, A Division of Tyco Healthc — 1 clearance
