Who is the manufacturer of MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED?

ETHICON, Inc. filed the 510(k) submission for MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (K964072).

What is the FDA product code for MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED?

GAN. It is classified under 21 CFR 878.4830 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED

Q: What are the predicate devices for MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED?

MONOCRYL (poliglecaprone 25) suture, dyed.

K964072 · ETHICON, Inc. · GAN · Dec 18, 1996 · General, Plastic Surgery

Device Facts

Record ID	K964072
Device Name	MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
Applicant	ETHICON, Inc.
Product Code	GAN · General, Plastic Surgery
Decision Date	Dec 18, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4830
Device Class	Class 2
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.

Indications for Use

Indicated for soft tissue approximation and/or ligation. Contraindicated for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.

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

MONOCRYL (poliglecaprone 25) suture, dyed

Related Devices

K081002 — MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE · Sutures India Pvt., Ltd. · Jun 9, 2008
K072863 — ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES · Internacional Farmaceutica, S.A. DE C.V. · May 23, 2008
K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) · ETHICON, Inc. · Mar 28, 1996
K141625 — POLYSYN SURGICAL SUTURE · Surgical Specialties Corp · Jul 18, 2014
K080412 — ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) · Shanghai Pudong Jinhuan Medical Products Co., Ltd. · Sep 4, 2008

Submission Summary (Full Text)

{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.