Fluorotex Surgical Mesh
FDA 510(k) K984197 · Bridger Biomed, Inc.
510(k) numberK984197
Submission
- Device name
- Fluorotex Surgical Mesh
- Applicant
- Bridger Biomed, Inc.
Bozeman, MT, US - Received
- November 23, 1998
- Decision date
- January 7, 1999
- 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
Other 510(k)s with product code FTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL · Traditional | Sofradim Production | 05/21/2026SE |
| 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 |
More from Davol Inc., Subsidiary of C. R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003917 | Modification to Fluorotex II Surgical MeshFTL · Traditional | 01/26/2001SE |
| K003906 | Modification to Flurotex Surgical MeshFTL · Traditional | 01/26/2001SE |
| K002351 | Fluorotex II Surgical MeshFTL · Traditional | 08/26/2000SE |
| K994032 | Fluoro-Tex Cardiovascular PatchDXZ · Traditional | 07/07/2000SE |
| K980548 | Dura-Patch Model Dp-XxxGXQ · Traditional | 05/13/1998SE |
| K973178 | Fluoro-Tex Surgical MembraneDXZ · Traditional | 11/24/1997SE |
Questions and answers
When was Fluorotex Surgical Mesh cleared by the FDA?
Fluorotex Surgical Mesh (K984197) received a 510(k) decision of Substantially Equivalent on January 7, 1999, 45 days after the submission was received.
What is the product code of K984197?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.