Kensey Nash Macropore Shield
FDA 510(k) K071695 · Kensey Nash Corp.
510(k) numberK071695
Submission
- Device name
- Kensey Nash Macropore Shield
- Applicant
- Kensey Nash Corp.
Exton, PA, US - Received
- June 20, 2007
- Decision date
- December 31, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K253125 | Parietene Flat Sheet MeshFTL · Special | Medtronic - Sofradim Production | 10/24/2025SE |
| K251955 | Onflex MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 07/24/2025SE |
| K251557 | Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special | Davol, Inc. | 06/12/2025SE |
| K250869 | Parietene Macroporous Mesh (PPM5050 )FTL · Special | Sofradim Production | 04/23/2025SE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional | Davol, Inc. | 04/09/2025SE |
| 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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|---|---|---|
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| K103787 | Medeor MatrixFTM · Traditional | 02/07/2011SE |
| K094061 | Kensey Nash Ecm Surgical PatchFTM · Traditional | 05/18/2010SE |
| K091192 | Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXNPL · Traditional | 11/02/2009SE |
| K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)FTM · Traditional | 10/22/2009SE |
| K090919 | Kensey Nash Fibrillar Collagen Dental MembraneNPL · Traditional | 10/02/2009SE |
| K073519 | Quickcat Extraction Catheter, Model 60090-01QEZ · Special | 03/28/2008SE |
| K073162 | Safe-Cross(R) Radio Frequency Total Occlusion Crossing System, Safe-Cross(R) Radio…DQX · Special | 02/08/2008SE |
| K072384 | Modification to Copios Bone Void Filler Sponge & PasteMQV · Special | 09/21/2007SE |
Questions and answers
When was Kensey Nash Macropore Shield cleared by the FDA?
Kensey Nash Macropore Shield (K071695) received a 510(k) decision of Substantially Equivalent on December 31, 2007, 194 days after the submission was received.
What is the product code of K071695?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.