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PERIPATCH SLEEVE - G35

by Pm Devices, Inc.

510(k) K033985

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 NumberK033985 Date4 Jun 2004ClearedStatusActive

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  • Withdrawn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
FTM
Models / Variants
G35
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Peripatch Sleeve is a surgical mesh device designed to reinforce tissue and support surgical repair procedures. It is classified as a prosthetic device under the category of surgical mesh, intended for use in plastic surgery applications to provide structural reinforcement to weakened or deficient tissue areas.

These sleeves are supplied sterile and intended for single-use. They are manufactured in multiple sizes (G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10) and are regulated under the FDA’s 510(k) clearance process, classified as Class II devices. They are intended for use in operating room settings and are not MRI-compatible. The device holds an FDA clearance under the traditional 510(k) pathway, with a decision date of June 4, 2004.

Other devices from Pm Devices, Inc.

Questions

AI-generated answers, 1 Oct 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 Peripatch Sleeve used for?

    The Peripatch Sleeve is a surgical mesh device designed specifically for plastic surgery applications. It provides structural reinforcement to weakened or deficient tissue areas, helping to support surgical repair procedures where tissue integrity is compromised. This makes it particularly useful in procedures requiring additional support to ensure long-term healing and stability.

  • How is the Peripatch Sleeve supplied, and is it sterile?

    The Peripatch Sleeve is supplied sterile, ensuring it is ready for immediate use in the operating room without additional sterilization. This is critical for maintaining patient safety and reducing the risk of infection during surgical procedures.

  • Is the Peripatch Sleeve intended for single-use or reuse?

    The Peripatch Sleeve is explicitly designed for single-use only. This is a standard practice for mesh devices to prevent cross-contamination between patients and to ensure consistent performance and sterility for each procedure.

  • What sizes are available for the Peripatch Sleeve?

    The Peripatch Sleeve comes in multiple sizes to accommodate different anatomical requirements: G35, E35, G45, E45, G60, E60, 5C6, 5C8, and 5C10. These variations allow surgeons to select the appropriate size based on the specific needs of the patient and the surgical site.

  • How should the Peripatch Sleeve be stored, and what are its regulatory details?

    The Peripatch Sleeve should be stored according to the manufacturer’s instructions to maintain its sterility and integrity. As a Class II device under the FDA’s 510(k) clearance process, it has been determined to be substantially equivalent to a predicate device and holds FDA clearance through the traditional 510(k) pathway, with a decision date of June 4, 2004. This ensures it meets established safety and effectiveness standards.