Prolene Polypropylene Mesh Hernia Device
by Ethicon Inc.
510(k) K972412
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972412 | Date10 Sep 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Prolene Polypropylene Mesh Hernia Device Nonabsorbable Synthetic Surgical Mesh
- 510(k) Number
- FDA product code
- FTL
- FDA applicant
- ETHICON, Inc.
- 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
The Prolene Polypropylene Mesh Hernia Device is a nonabsorbable synthetic surgical mesh made from polypropylene. It is classified as a Class II medical device and is designed to reinforce weakened abdominal walls, providing structural support during hernia repair procedures. The mesh is intended for use in open ventral and inguinal hernia repairs, offering durability and flexibility to promote tissue integration and reduce recurrence rates.
This device is supplied sterile and intended for single-use. It is not MRI-safe and must be handled with sterile technique in an operating room setting. Available in various sizes, the mesh is regulated under FDA 510(k) clearance (K972412) and falls under the product code FTL. The device is manufactured by Ethicon Inc. and adheres to regulatory standards for surgical meshes, ensuring compliance with the requirements for hernia repair applications.
Other devices from Ethicon Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Prolene Polypropylene Mesh Hernia Device used for?
The Prolene Polypropylene Mesh Hernia Device is designed to reinforce weakened abdominal walls during hernia repair procedures. It provides structural support to prevent hernia recurrence by promoting tissue integration, making it suitable for both open ventral and inguinal hernia repairs.
How is the Prolene Polypropylene Mesh Hernia Device supplied and prepared for use?
The mesh is supplied sterile and intended exclusively for single-use in an operating room setting. It must be handled using sterile technique to maintain its integrity and prevent contamination before implantation.
Is the Prolene Polypropylene Mesh Hernia Device safe for MRI procedures?
No, the Prolene Polypropylene Mesh Hernia Device is not MRI-safe. Patients implanted with this mesh should avoid MRI scans, as the device may cause heating or artifacts that could interfere with imaging or pose safety risks.
What sizes are available for the Prolene Polypropylene Mesh Hernia Device?
The Prolene Polypropylene Mesh Hernia Device comes in multiple sizes to accommodate different patient anatomies and hernia repair requirements. Exact sizing details should be referenced in the product documentation or packaging, as variations are tailored for specific surgical applications.
How should the Prolene Polypropylene Mesh Hernia Device be stored?
The mesh should be stored in its original, unopened packaging to preserve sterility. It must be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Follow manufacturer guidelines for expiration dates and storage conditions to ensure optimal performance.