Skip to content

Phasix ST Umbilical Hernia Patch

by Davol, Inc., A Subsidiary of C.R. Bard, Inc.

510(k) K243241

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243241 Date19 Feb 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
OWT
Device Class
Class II
Regulation
21 CFR Part 878.3300
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 Phasix ST Umbilical Hernia Patch is an absorbable surgical mesh designed for open umbilical hernia repairs. Classified as a surgical mesh for abdominal hernia repair, it provides structural reinforcement to the hernia defect while being gradually absorbed by the body over time.

This device is supplied sterile and intended for single-use in surgical settings. It features a pocket-and-strap design to facilitate precise placement and lateral fixation, aiding in consistent repair techniques. Regulated under 21 CFR 878.3300 with FDA 510(k) clearance (K243241), it is categorized under Product Code OWT and reviewed by the General, Plastic Surgery Advisory Committee.

Other devices from Davol, Inc., A Subsidiary of C.R. Bard, 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 umbilical hernia repairs is the Phasix ST Umbilical Hernia Patch designed for, and how does its pocket-and-strap design help during surgery?

    The Phasix ST Umbilical Hernia Patch is specifically designed for open umbilical hernia repairs, providing absorbable structural reinforcement to the hernia defect. Its pocket-and-strap design facilitates precise placement and lateral fixation, which helps surgeons achieve consistent and secure repair techniques by reducing slippage and improving mesh stability during suturing.

  • Is the Phasix ST Umbilical Hernia Patch intended for reuse in multiple procedures, or is it meant to be used only once?

    The Phasix ST Umbilical Hernia Patch is intended for single-use only, as explicitly stated in its description. This aligns with standard surgical mesh practices to ensure sterility and patient safety, as it is supplied sterile and not designed for reprocessing or reuse.

  • What regulatory pathway was followed for FDA clearance of the Phasix ST Umbilical Hernia Patch, and which advisory committee reviewed it?

    The Phasix ST Umbilical Hernia Patch received FDA 510(k) clearance (K243241) under the traditional review pathway, categorized under Product Code OWT and regulated by 21 CFR 878.3300. It was reviewed by the General, Plastic Surgery Advisory Committee (SU), reflecting its classification as a surgical mesh for abdominal hernia repair.

  • How is the Phasix ST Umbilical Hernia Patch packaged and stored to maintain its sterility before use?

    While the exact packaging details aren’t specified, the device is supplied sterile for surgical use, meaning it is likely packaged in a sterile barrier system (e.g., sterile pouch or tray) to preserve sterility. Standard practice for absorbable surgical meshes dictates storage in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use, as per manufacturer guidelines.