PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
Device Facts
| Record ID | K961931 |
|---|---|
| Device Name | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP |
| Applicant | R. K. Medical L. L. C. |
| Product Code | GAL · General, Plastic Surgery |
| Decision Date | Jul 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4830 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Plain and chromic gut surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Story
Absorbable, sterile surgical sutures; composed of purified connective tissue (collagen) from bovine serosal layer or ovine submucosal fibrous layer; packaged in fluid (isopropanol, water, triethanolamine); sterilized via gamma irradiation. Used by surgeons for soft tissue approximation/ligation. 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 methods confirms compliance with USP specifications and equivalence to predicate.
Technological Characteristics
Material: Purified connective tissue (collagen) from bovine or ovine intestines. Sterilization: Gamma irradiation. Packaging: Isopropanol, water, triethanolamine fluid. Compliance: USP XXIII standards for physical and mechanical properties.
Indications for Use
Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for cardiovascular and neurological procedures.
Regulatory Classification
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.
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
- Davis & Geck plain and chromic gut surgical sutures
Related Devices
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- K994002 — PLAIN/CHROMIC CATGUT · Trading Consultants and Distributors Intl., Inc. · Feb 4, 2000
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- K991223 — ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC · Aesculap, Inc. · Apr 30, 1999
