← Product Code [GAN](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN) · K964072 # MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (K964072) _ETHICON, Inc. · GAN · Dec 18, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN/K964072 ## Device Facts - **Applicant:** ETHICON, Inc. - **Product Code:** [GAN](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN.md) - **Decision Date:** Dec 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4830 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation. ## Device Story MONOCRYL (poliglecaprone 25) suture, undyed; monofilament synthetic absorbable surgical suture; copolymer of glycolide and epsilon-caprolactone. Used by surgeons for general soft tissue approximation and ligation. Device provides mechanical support during healing; identical breaking strength retention (BSR) profile to dyed predicate. No changes in material or chemical composition. ## Clinical Evidence Bench testing only. Nonclinical laboratory testing performed to evaluate breaking strength retention (BSR) profile after implantation; results confirmed BSR profile is identical to predicate device. ## Technological Characteristics Monofilament synthetic absorbable suture; copolymer of glycolide and epsilon-caprolactone. Identical material and chemical composition to predicate. No software or electronic components. ## Regulatory 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 - MONOCRYL (poliglecaprone 25) suture, dyed ## 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} DEC 18 1996 SECTION 7 K964072 # SUMMARY OF SAFETY AND EFFECTIVENESS | 510(k) Summary of Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. MODIFIED DEVICE NAME: MONOCRYL (poliglecaprone 25) suture, undyed PREDICATE DEVICE NAME: MONOCRYL (poliglecaprone 25) suture, dyed 510(k) SUMMARY | | --- | --- | | Device Description | MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. | | Intended Use | MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation. MONOCRYL suture, undyed has the same intended use as predicate device MONOCRYL suture, dyed. Continued on next page | MONOCRYL (poliglecaprone 25) suture, undyed ETHICON, Inc. 23 {1} SUMMARY OF SAFETY AND EFFECTIVENESS, Continued 510(k) SUMMARY, Continued Indications Statement Modified MONOCRYL sutures, undyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. Technological Characteristics The modified device has the same technological characteristics as the predicate device. There is no change in material or chemical compound. Modified MONOCRYL suture, undyed has an increased breaking strength retention (BSR) profile identical to the predicate device. Performance Data Nonclinical laboratory testing was performed to determine breaking strength retention profile after implantation. It was determined that the BSR profile for Modified MONOCRYL suture, undyed is identical to the predicate device. Conclusions Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. Contact John D. Paulson, Ph.D. Vice President, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 Date October 9, 1996 MONOCRYL (poliglecaprone 25) suture, undyed ETHICON, Inc. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN/K964072](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN/K964072) **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