Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System
FDA 510(k) K110820 · C.R. Bard, Inc.
510(k) numberK110820
Submission
- Device name
- Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System
- Applicant
- C.R. Bard, Inc.
Warwick, RI, US - Received
- March 23, 2011
- Decision date
- April 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTL – Mesh, Surgical, Polymeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K251955 | Onflex MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 07/24/2025SE |
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| K243315 | ProGrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/17/2025SE |
| K241250 | 3DMax Light MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 06/14/2024SE |
| K232373 | Progrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/18/2024SE |
| K233402 | Bard 3DMax MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 11/01/2023SE |
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Questions and answers
When was Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System cleared by the FDA?
Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (K110820) received a 510(k) decision of Substantially Equivalent on April 1, 2011, 9 days after the submission was received.
What is the product code of K110820?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.