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Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042026

by C. R. Bard, Inc.

Identifiers

510(k) Number
K042026 FDA 510(k)
FDA Product Code
FTL FDA 510(k)
Models / Variants
0118001 FDA 510(k)
0118002 FDA 510(k)
0118003 FDA 510(k)
0118004 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard CK Parastomal Hernia Patch is a surgical mesh device classified as Mesh, Surgical, Polymeric. It is designed to reinforce and repair soft tissue deficiencies, including abdominal wall defects and parastomal hernias, by providing structural support during reconstructive procedures.

This device is supplied sterile and intended for single-use. It is classified under product code FTL and falls under FDA 510(k) clearance with a traditional review process. The patch is intended for use in surgical settings and is regulated under the FDA’s special controls for Class II devices, specifically for general and plastic surgery applications.

Frequently asked questions

What is the primary purpose of the Bard CK Parastomal Hernia Patch in surgical procedures?

The Bard CK Parastomal Hernia Patch is designed to reinforce and repair soft tissue deficiencies, specifically abdominal wall defects and parastomal hernias. It provides structural support during reconstructive surgeries to help stabilize the area and reduce the risk of recurrence.

How is the Bard CK Parastomal Hernia Patch supplied, and is it intended for single-use or reuse?

The patch is supplied sterile and is explicitly intended for single-use only, meaning it should not be reused after a surgical procedure to ensure patient safety and maintain sterility.

What regulatory pathway was followed for the FDA clearance of this device, and what type of review process was used?

The Bard CK Parastomal Hernia Patch received FDA clearance through a 510(k) submission, classified under product code FTL for surgical mesh. The clearance was granted via a traditional review process, meaning a detailed evaluation by the FDA was conducted to determine its substantial equivalence to a predicate device.

Are there multiple models available for the Bard CK Parastomal Hernia Patch, and if so, how would a clinician determine which one to use?

Yes, the Bard CK Parastomal Hernia Patch comes in four models (0118001, 0118002, 0118003, 0118004), though the specific sizing or application differences between them are not detailed in the provided data. Clinicians should refer to the manufacturer’s surgical guidelines or consult with Bard’s technical support to select the appropriate model based on the patient’s anatomy and hernia characteristics.

What medical specialties are primarily associated with the use of this device, and why?

The Bard CK Parastomal Hernia Patch is regulated under the FDA’s General and Plastic Surgery specialties, as indicated by its advisory committee designation (SU). This reflects its intended use in reconstructive surgeries for abdominal wall defects and parastomal hernias, which are commonly addressed by surgeons in these specialties.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bard Ck Parastomal Hernia Patch, Models 0118001, 0118002, 0118003 ..., Bard Ck Parastomal Hernia Patch, Models 0118001, 0118002, 0118003 ..., PDF BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001… - FDA.report, BARD CK PARASTOMAL HERNIA PATCH, MODELS... (K042026) - FDA 510(k), BARD CK PARASTOMAL HERNIA PATCH, MODELS... (K042026) - FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K042026 24 fields · synced Sep 19, 2026