GAO · Suture, Nonabsorbable
General, Plastic Surgery · 21 CFR 878.4495 · Class 2
Overview
| Product Code | GAO |
|---|---|
| Device Name | Suture, Nonabsorbable |
| Regulation | 21 CFR 878.4495 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
Classification Rationale
Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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 device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Alto Development Corp. | Jan 7, 1994 | SESE |
| K872532 | AUTO SUTURE STAINLESS STEEL SUTURES* | United States Surgical, A Division of Tyco Healthc | Aug 5, 1987 | SESE |
| K863034 | SHARPOINT STAINLESS STEEL SUTURE | Chathamborough Research Group, Inc. | Sep 30, 1986 | SESE |
| K802248 | DISARP ORIGINAL | Unoplast A/S | Sep 26, 1980 | SESE |
Top Applicants
- Alto Development Corp. — 1 clearance
- Chathamborough Research Group, Inc. — 1 clearance
- United States Surgical, A Division of Tyco Healthc — 1 clearance
- Unoplast A/S — 1 clearance
