Who is the manufacturer of MODIFIED USSC* POLYSORB SUTURE?

United States Surgical, A Division of Tyco Healthc filed the 510(k) submission for MODIFIED USSC* POLYSORB SUTURE (K970863).

What is the FDA product code for MODIFIED USSC* POLYSORB SUTURE?

GAM. It is classified under 21 CFR 878.4493 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MODIFIED USSC* POLYSORB SUTURE?

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

What are the predicate devices for MODIFIED USSC* POLYSORB SUTURE?

USSC* Braided Synthetic Absorbable Suture (K961997); USSC* POLYSORB* Sutures (K963253).

Who can help prepare an FDA 510(k) submission like MODIFIED USSC* POLYSORB SUTURE?

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.

MODIFIED USSC* POLYSORB SUTURE

K970863 · United States Surgical, A Division of Tyco Healthc · GAM · May 5, 1997 · General, Plastic Surgery

Device Facts

Record ID	K970863
Device Name	MODIFIED USSC* POLYSORB SUTURE
Applicant	United States Surgical, A Division of Tyco Healthc
Product Code	GAM · General, Plastic Surgery
Decision Date	May 5, 1997
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 878.4493
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Modified USSC* POLYSORB* Sutures are indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Device Story

Synthetic absorbable surgical suture; composed of LACTOMER glycolide/lactide copolymer; coated with caprolactone/glycolide copolymer and calcium stearoyl lactylate. Used by surgeons for soft tissue approximation or ligation and ophthalmic procedures. Provides temporary wound support during healing process; absorbed by body over time.

Clinical Evidence

Bench testing only. Device meets U.S.P. Synthetic Absorbable Suture Monograph requirements for tensile strength, needle attachment, and diameter.

Technological Characteristics

Synthetic absorbable suture; material: LACTOMER glycolide/lactide copolymer; coating: caprolactone/glycolide copolymer and calcium stearoyl lactylate. Performance meets U.S.P. Synthetic Absorbable Suture Monograph standards.

Indications for Use

Indicated for soft tissue approximation or ligation and ophthalmic surgery. Contraindicated for cardiovascular or neural tissue.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

USSC* Braided Synthetic Absorbable Suture (K961997)
USSC* POLYSORB* Sutures (K963253)

Related Devices

K964345 — ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED · ETHICON, Inc. · Dec 16, 1996
K981935 — POLYSORB SUTURE · United States Surgical, A Division of Tyco Healthc · Jun 25, 1998
K974299 — PANACRYL · ETHICON, Inc. · Feb 13, 1998
K014021 — SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED · Surgical Specialties Corp · Jan 28, 2002
K022269 — COATED VICRYL* (POLYGLACTIN 910) SUTURE · ETHICON, Inc. · Sep 13, 2002

Submission Summary (Full Text)

{0} K970863 MAY -5 1997 # UNITED STATES SURGICAL CORPORATION ## 510(k) PREMARKET NOTIFICATION ### Modified USSC* POLYSORB* Suture** # SUMMARY ## 510(K) SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS **SUBMITTER:** United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 **CONTACT PERSON:** Jonathan Gilbert **DATE PREPARED:** March 6, 1997 **CLASSIFICATION NAME:** Absorbable Surgical Suture **COMMON NAME:** Synthetic Absorbable Surgical Suture **PROPRIETARY NAME:** The trademark name of this device has not yet been determined. **PREDICATE DEVICE:** USSC* Braided Synthetic Absorbable Suture** (K961997) and USSC* POLYSORB* Sutures (K963253) **DEVICE DESCRIPTION:** Modified USSC* POLYSORB* sutures are composed of LACTOMER* glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate. **INTENDED USE:** Modified USSC* POLYSORB* Sutures are indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. **MATERIALS** Modified USSC* POLYSORB* sutures are composed of LACTOMER* glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). **PERFORMANCE:** Meets the requirements of U.S.P. Synthetic Absorbable Suture Monograph for tensile strength, needle attachment and diameter. *Trademark of United states Surgical Corporation **Trademark name not yet determined 17