Bioblanket Surgical Mesh
FDA 510(k) K061030 · Kensey Nash Corporation
510(k) numberK061030
Submission
- Device name
- Bioblanket Surgical Mesh
- Applicant
- Kensey Nash Corporation
Exton, PA, US - Received
- April 14, 2006
- Decision date
- May 9, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | Boston Scientific | 08/12/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | Aroa Biosurgery , Ltd. | 06/03/2025SE |
| K243595 | OviTex PRS (Long-Term Resorbable)FTM · Special | TELA Bio, Inc. | 12/19/2024SE |
| K233991 | CanGaroo RM Antibacterial EnvelopeFTM · Traditional | Elutia, Inc. | 06/14/2024SE |
| K241126 | OviTex PRSFTM · Special | TELA Bio, Inc. | 05/22/2024SE |
| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | Synovis Life Technologies, Inc. | 04/07/2023SE |
| K214070 | OviTex PRS (Long Term Resorbable)FTM · Traditional | Tela Bio | 03/21/2023SE |
| K213163 | VersaWrapFTM · Special | Alafair Biosciences, Inc. | 10/29/2021SE |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special | Synovis Life Technologies. Inc. (A Subsidiary of… | 10/27/2021SE |
| K203496 | Nexo-Gide Bilayer Collagen MembraneFTM · Traditional | Geistlich Pharma AG | 07/14/2021SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K121310 | Mesothelium Dental MembraneNPL · Traditional | 07/11/2013SE |
| K112888 | Meso Wound MatrixKGN · Traditional | 02/10/2012SE |
| 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 |
| K071695 | Kensey Nash Macropore ShieldFTL · Traditional | 12/31/2007SE |
Questions and answers
When was Bioblanket Surgical Mesh cleared by the FDA?
Bioblanket Surgical Mesh (K061030) received a 510(k) decision of Substantially Equivalent on May 9, 2006, 25 days after the submission was received.
What is the product code of K061030?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.