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Proxifast Absorbable Staple

by Surgimatix, Inc.

510(k) K132669

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 NumberK132669 Date13 Jan 2014ClearedStatusActive

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  • Withdrawn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
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Proxifast Absorbable Staple is a Staple, Implantable (per FDA nomenclature) designed for temporary tissue approximation. These staples are intended to provide secure closure of soft tissue layers, particularly in procedures requiring absorbable fasteners.

Used in abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgeries, the Proxifast Absorbable Staple is applied via a manual surgical stapler for subtuticular skin closure in tissues approximately 1–5 mm thick. Supplied as a single-use device, it is classified under FDA regulation 878.4750 and holds an FDA 510(k) clearance (K132669) as substantially equivalent. Sterility and packaging details are not specified in the available data.

Other devices from Surgimatix, Inc.

Questions

AI-generated answers, 19 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 types of surgical procedures is the Proxifast Absorbable Staple commonly used for, and what tissue thickness is it designed to approximate?

    The Proxifast Absorbable Staple is designed for temporary tissue approximation in procedures like abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgeries. It is specifically intended for subtuticular skin closure in tissues approximately 1–5 mm thick, ensuring secure fastening where absorbable fasteners are preferred.

  • How is the Proxifast Absorbable Staple applied, and is it reusable or single-use?

    The Proxifast Absorbable Staple is applied using a manual surgical stapler, which is a key part of its intended use. The device itself is single-use only, meaning each package should be discarded after application to maintain sterility and performance.

  • Are there multiple sizes or models of the Proxifast Absorbable Staple, and if so, how are they differentiated?

    While the provided data lists multiple FDA registration numbers, it does not specify distinct sizes or models beyond the general description of being designed for 1–5 mm thick tissues. Differentiation (e.g., staple length, gauge, or packaging) would require additional product documentation from the manufacturer.

  • What regulatory pathway was followed for FDA clearance of the Proxifast Absorbable Staple, and which advisory committee reviewed it?

    The Proxifast Absorbable Staple received FDA 510(k) clearance (K132669) under the Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device. The review was conducted by the Surgical Devices Panel (SU) of the General and Plastic Surgery Advisory Committee, as indicated in the submission details.