3DMAX Light Mesh, Models 0117310, 0117311, 0117312, 0117320, 0117321, 011732
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091659 FDA 510(k)
- FDA Product Code
- FTL 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 3DMAX Light Mesh is a surgical mesh designed for reinforcing soft tissue, particularly in hernia repair. Constructed from knitted polypropylene monofilaments (0.0048-inch diameter), it provides a lightweight, anatomically shaped solution for laparoscopic inguinal hernia reinforcement. Its large-pore knit structure supports tissue integration while minimizing weight and bulk, making it suitable for procedures such as TAPP, TEP, and Robotic TAPP.
Supplied sterile and intended for single-use, the mesh is intended for use in operating rooms during laparoscopic hernia repair. Models vary in size, including dimensions such as 4.1 in x 6.2 in (10.3 cm x 15.7 cm), and are classified as a Class II device under FDA regulations. It requires proper handling, including avoidance of cutting or reshaping, and fixation using Bard permanent or absorbable devices or nonabsorbable monofilament sutures. No MRI safety information is specified.
Frequently asked questions
What is the Bard 3DMAX Light Mesh used for?
The Bard 3DMAX Light Mesh is designed specifically for reinforcing soft tissue during hernia repair, particularly in laparoscopic inguinal hernia procedures. Its lightweight, anatomically shaped design and large-pore knit structure make it ideal for reinforcing the inguinal region using techniques like TAPP (Transabdominal Preperitoneal), TEP (Totally Extraperitoneal), and Robotic TAPP. The mesh integrates with surrounding tissue while minimizing bulk, helping to prevent hernia recurrence.
How is the Bard 3DMAX Light Mesh supplied and what are its key dimensions?
The Bard 3DMAX Light Mesh is supplied sterile and intended for single-use in operating rooms. It comes in multiple models (0117310, 0117311, 0117312, 0117320, 0117321, 011732) with varying dimensions, including a common size of 4.1 inches by 6.2 inches (10.3 cm x 15.7 cm). The exact dimensions depend on the specific model, so refer to the packaging for precise measurements before use.
Is the Bard 3DMAX Light Mesh reusable or single-use?
The Bard 3DMAX Light Mesh is explicitly intended for single-use only. It is supplied sterile to ensure patient safety and prevent contamination. Reusing this mesh could compromise sterility and integrity, potentially leading to complications during surgery.
How should the Bard 3DMAX Light Mesh be handled and fixed in place?
The Bard 3DMAX Light Mesh should be handled with care to avoid cutting, reshaping, or damaging the material. It is designed to be fixed in place using Bard’s permanent or absorbable fixation devices, or non-absorbable monofilament sutures. Proper fixation ensures the mesh remains securely positioned during tissue integration and healing.
Are there any special storage requirements for the Bard 3DMAX Light Mesh?
The Bard 3DMAX Light Mesh should be stored in its original, unopened packaging to maintain sterility. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Do not refrigerate or freeze the mesh, as this could affect its structural integrity. Always check the expiration date before use.
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 3dmax Light Mesh, Models: 0117310, 0117311, 0117312, 0117320 ..., 3DMax™ Light Mesh, Large Left, 4.1 in x 6.2 in (10.3 cm x 15.7 ... - BD, 3DMax™ Light Mesh - BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091659 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K091659 24 fields · synced Oct 1, 2026