NYLON NOABSORBABLE SURGICAL SUTURES USP
Device Facts
| Record ID | K960327 |
|---|---|
| Device Name | NYLON NOABSORBABLE SURGICAL SUTURES USP |
| Applicant | R. K. Medical L. L. C. |
| Product Code | GAR · General, Plastic Surgery |
| Decision Date | Mar 4, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The nylon 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
Nylon nonabsorbable surgical sutures; monofilament or braided; coated (silicone/wax) or uncoated; dyed (black/blue) or undyed. Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device provides mechanical closure of tissue; maintains tensile strength during healing. Performance verified via USP XXIII standards for diameter, length, knot pull tensile strength, and needle attachment strength.
Clinical Evidence
Bench testing only. Testing performed per USP XXIII methods for suture diameter, length, knot pull tensile strength, and needle attachment strength. Results confirm compliance with USP specifications and equivalence to predicate.
Technological Characteristics
Synthetic polyamide (nylon) suture; monofilament or braided construction; optional silicone or wax coating; dyed or undyed. Complies with USP XXIII specifications for physical and mechanical properties. Sterilization method not specified.
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
Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
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
- Nylon nonabsorbable surgical sutures manufactured by Davis + Geck
Related Devices
- K960328 — SILK NONABSORBABLE SURGICAL SUTURES USP · R. K. Medical L. L. C. · Mar 4, 1996
- K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture · M/s. Meril Endo Surgery Private Limited. · May 31, 2016
- K023028 — DEMETECH NYLON NONABSORBABLE SUTURE · Demetech Corp. · Jun 18, 2003
- K981582 — SURGILON, DERMALON, & OPHTHALON · Davis & Geck, Inc. · Jul 13, 1998
- K091574 — SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES · Supplidores Unidos Internacionales, S.A. · Oct 9, 2009
