← Product Code [GAW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAW) · K961389 # POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (K961389) _R. K. Medical L. L. C. · GAW · Jun 18, 1996 · General, Plastic Surgery · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAW/K961389 ## Device Facts - **Applicant:** R. K. Medical L. L. C. - **Product Code:** [GAW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAW.md) - **Decision Date:** Jun 18, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5010 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Polypropylene nonabsorbable surgical sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. ## Device Story Monofilament polypropylene nonabsorbable surgical suture; dyed blue [phthalocyaninato (2-)] copper; used for soft tissue approximation and ligation; utilized in cardiovascular, ophthalmic, and neurological procedures; provides mechanical wound closure; 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 standards for suture diameter, length, knot pull tensile strength, and needle attachment strength. Results demonstrate compliance with USP specifications and equivalence to predicate. ## Technological Characteristics Monofilament polypropylene; dyed blue [phthalocyaninato (2-)] copper; sterile; meets USP XXIII specifications for physical and mechanical properties. ## Regulatory Identification Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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 - Surgilene polypropylene nonabsorbable surgical sutures (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} R.K. MEDICAL 35 EAGLE ROAD • DANBURY, CT 06810 U.S.A. PHONE: (203) 797-8700 • FAX: (203) 792-1465 510(k) SUMMARY JUN 18 1996 K 961389 "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** April 4, 1996 **Name of Device** Common or Usual Name: Polypropylene Nonabsorbable Surgical Sutures Classification Name: Suture, nonabsorbable, synthetic, Polypropylene Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck. The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [phthalocyaninato (2-)] copper. The Polypropylene nonabsorbable surgical 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 polypropylene sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to polypropylene sutures manufactured by Davis+Geck. John A. Hutter, Plant Manager -37- --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAW/K961389](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAW/K961389) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com