← Product Code [GAR](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAR) · K960327 # NYLON NOABSORBABLE SURGICAL SUTURES USP (K960327) _R. K. Medical L. L. C. · GAR · Mar 4, 1996 · General, Plastic Surgery · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAR/K960327 ## Device Facts - **Applicant:** R. K. Medical L. L. C. - **Product Code:** [GAR](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAR.md) - **Decision Date:** Mar 4, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5020 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K960327 1 of 1 # R.K. MEDICAL 35 EAGLE ROAD • DANBURY, CT 06810 U.S.A. PHONE: (203) 797-8700 • FAX: (203) 792-1465 510(k) SUMMARY **MAR - 4 1996** "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92." ## Applicant R. K. Medical L. L. C. 35 Eagle Road Danbury, CT 06810 Tel: (203) 797-8700 Fax: (203) 792-1465 ## Contact John A. Hutter, Plant Manager or George R. Krebs (President) ## Date January 23, 1996 ## Name of Device: Common or Usual Name: Nylon Nonabsorbable Surgical Sutures Classification Name: Suture, nonabsorbable, synthetic polyamide Nylon nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to nylon nonabsorbable surgical sutures manufactured by Davis + Geck. The nylon sutures manufactured by R. K. Medical and D+G can be monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or blue or undyed. 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. Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength according to methods outlined in USP XXIII demonstrates that R. K. Medical nylon sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to nylon sutures manufactured by Davis + Geck. John A. Hutter, Plant Manager --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAR/K960327](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAR/K960327) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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