SILK NONABSORBABLE SURGICAL SUTURES USP
Device Facts
| Record ID | K960328 |
|---|---|
| Device Name | SILK NONABSORBABLE SURGICAL SUTURES USP |
| Applicant | R. K. Medical L. L. C. |
| Product Code | GAP · General, Plastic Surgery |
| Decision Date | Mar 4, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Story
Silk nonabsorbable surgical sutures; twisted or braided construction; available coated (silicone or wax) or uncoated; dyed (Logwood) or undyed. Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device provides mechanical closure of tissue; performance verified against USP XXIII standards for diameter, length, knot pull tensile strength, and needle attachment strength.
Clinical Evidence
Bench testing only. Testing of suture diameter, length, knot pull tensile strength, and needle attachment strength per USP XXIII demonstrates compliance with USP specifications and equivalence to predicate.
Technological Characteristics
Nonabsorbable silk suture; twisted or braided; silicone or wax coating; Logwood dye or undyed. Meets USP XXIII specifications for physical and mechanical properties.
Indications for Use
Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. No specific age or gender restrictions noted.
Regulatory Classification
Identification
Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
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.
Predicate Devices
- Silk nonabsorbable surgical sutures (Davis + Geck)
Related Devices
- K960327 — NYLON NOABSORBABLE SURGICAL SUTURES USP · R. K. Medical L. L. C. · Mar 4, 1996
- K024091 — SILK SUTURES · Aurolab · Feb 28, 2003
- K993999 — SILK · Trading Consultants and Distributors Intl., Inc. · Feb 4, 2000
- K012124 — MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP · Johnson & Johnson Medical (China) , Ltd. · Sep 19, 2001
- K023029 — DEMETECH SILK NONABSORBABLE SUTURE · Demetech Corp. · Nov 25, 2002
