Porcine Surgical Mesh, Porcine Dermal Matrix
FDA 510(k) K111436 · Brennen Medical, LLC
510(k) numberK111436
Submission
- Device name
- Porcine Surgical Mesh, Porcine Dermal Matrix
- Applicant
- Brennen Medical, LLC
St. Paul, MN, US - Received
- May 24, 2011
- Decision date
- October 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K113866 | Porcine Dermal Xenografts Porcine Dermal MatrixKGN · Traditional | 03/23/2012SE |
| K081272 | Porcine Surgical Mesh; Dermal MatrixFTM · Traditional | 07/31/2008SE |
| K050086 | Brennen Medical Silver Glucan Wound DressingFRO · Traditional | 02/17/2006SE |
| K030460 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | 03/07/2003SE |
| K021835 | Brennen Medical Surgical Mesh, Glucamesh/GlucatexFTL · Traditional | 10/17/2002SE |
| K002078 | Beta Glucan Gel (Macropro Gel)MGQ · Traditional | 10/02/2000SE |
| K002077 | Glucanpro CreamMGQ · Traditional | 10/02/2000SE |
| K000519 | GlucanproMGQ · Traditional | 05/01/2000SE |
| K000518 | Macropro GelMGQ · Traditional | 05/01/2000SE |
| K982825 | Brennen Medical Beta Glucan GelMGQ · Traditional | 11/06/1998SE |
Questions and answers
When was Porcine Surgical Mesh, Porcine Dermal Matrix cleared by the FDA?
Porcine Surgical Mesh, Porcine Dermal Matrix (K111436) received a 510(k) decision of Substantially Equivalent on October 14, 2011, 143 days after the submission was received.
What is the product code of K111436?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.