← Product Code [GAM](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM) · K963253

# SYNTHETIC ABSORBABLE SURGICAL SUTURE (K963253)

_United States Surgical, A Division of Tyco Healthc · GAM · Oct 8, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K963253

## Device Facts

- **Applicant:** United States Surgical, A Division of Tyco Healthc
- **Product Code:** [GAM](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM.md)
- **Decision Date:** Oct 8, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4493
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

USSC* POLYSORB* CSL** sutures are indicated for use in general soft tissue approximation and/ or ligation and ophthalmic surgery but not use in cardiovascular or neural tissue.

## Device Story

USSC POLYSORB CSL suture; synthetic absorbable surgical suture; used for soft tissue approximation and ligation; ophthalmic surgery application; device functions as mechanical support for tissue healing; sterile, single-use; intended for use by surgeons in clinical settings.

## Clinical Evidence

No clinical data; substantial equivalence based on material composition, manufacturing, and intended use similarity to predicate.

## Technological Characteristics

Synthetic absorbable suture; biosafe materials; manufactured and sterilized using established processes consistent with existing USSC POLYSORB product line.

## Regulatory 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 POLYSORB suture

## Submission Summary (Full Text)

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K963253

OCT - 8 1996

UNITED STATES SURGICAL CORPORATION

510(K) PREMARKET NOTIFICATION

USSC* POLYSORB* CSL** SUTURE

# 510(k) SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

As is evident in the submitted information on function, indications and materials, USSC* POLYSORB* CSL** sutures are substantially equivalent to the currently marketed USSC* POLYSORB* suture as summarized below:

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are composed of biosafe materials.

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and/ or ligation and ophthalmic surgery but not use in cardiovascular or neural tissue.

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are manufactured in the same facilities using similar processes and controls.

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are packaged in the same facilities using similar materials, processes and controls.

- USSC* POLYSORB* CSL** sutures and other products currently marketed by United States Surgical Corporation are sterilized in the same facilities using similar processes and controls.

*Trademark of United states Surgical Corporation

**Trademark name not yet determined

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K963253](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAM/K963253)

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