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NeatStitch NeatClose Suturing Device

by Neat Stitch, Ltd.

510(k) K063462

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063462 Date12 Jan 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAM
FDA applicant
Neat Stitch , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4493
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NeatStitch NeatClose Suturing Device is a suture, absorbable, synthetic, polyglycolic acid device intended for the approximation and/or ligation of soft tissues in laparoscopic procedures. It is classified as a Class II medical device under product code GAM and regulation number 878.4493.

The device received FDA 510(k) clearance (K063462) on January 12, 2007, and is substantially equivalent to a predicate device. It is manufactured by Neat Stitch, Ltd. in Or Akiva, Israel, and is supplied as a single-use device for use in general and plastic surgery settings.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NeatStitch NeatClose Suturing Device used for?

    It is intended for the approximation and/or ligation of soft tissues during laparoscopic procedures, specifically in general and plastic surgery settings, to close or tie tissues using absorbable synthetic suture material.

  • Is the NeatStitch NeatClose Suturing Device reusable or single-use?

    The device is supplied as a single-use device, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device integrity.

  • What material is the suture made of in the NeatStitch NeatClose device?

    The suture is made of absorbable synthetic polyglycolic acid, a biocompatible polymer that gradually breaks down in the body over time, eliminating the need for suture removal.

  • How is the NeatStitch NeatClose Suturing Device supplied and stored?

    It is supplied as a sterile, single-use unit and should be stored in accordance with the manufacturer’s instructions, typically in a cool, dry place away from direct sunlight to maintain sterility and material stability until use.