← Product Code [GAT](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT) · K961925 # POLYESTER NONABSORBABLE SURGICAL SUTURES USP (K961925) _R. K. Medical L. L. C. · GAT · Jul 29, 1996 · General, Plastic Surgery · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K961925 ## Device Facts - **Applicant:** R. K. Medical L. L. C. - **Product Code:** [GAT](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT.md) - **Decision Date:** Jul 29, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5000 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The polyester 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 Polyester nonabsorbable surgical sutures; braided, silicone-coated; dyed green (D&C Green #6). Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device provides mechanical closure of tissue; performance verified via USP XXIII standards for diameter, length, knot pull tensile strength, and needle attachment strength. ## Clinical Evidence Bench testing only. Testing of suture diameter, suture length, knot pull tensile strength, and needle attachment strength performed according to USP XXIII methods. ## Technological Characteristics Braided polyester fiber; silicone coating; dyed with D&C Green #6. Nonabsorbable. Meets USP XXIII specifications for surgical sutures. ## Regulatory Identification Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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 - Ti-cron polyester nonabsorbable surgical suture (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 JUL 29 1996 K961925 # 510 (k) SUMMARY "This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92." ## Applicant: R.K. Medical L.L.C. 35 Eagle Road Danbury, CT 06810 Tele: (203) 797-8700 Fax: (203) 792-1465 ## Contact: Mr. John A. Hutter, Plant Manager or Mr. George R. Krebs, President Date: 5/15/96 ## Name of Device: Common or Usual Name: Polyester Nonabsorbable Surgical Sutures Classification Name: Suture, Nonabsorbable, Synthetic, Polyester Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck. The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck’s Ti-cron* is dyed blue (D&C Blue #6). The polyester 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 described in USP XXIII demonstrates that R.K. Medical Polyester nonabsorbable surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to polyester nonabsorbable surgical sutures manufactured by Davis & Geck. John A. Hutter, Plant Manager --40-- --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K961925](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAT/K961925) **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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