Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205
FDA 510(k) K003323 · Davol, Inc.
510(k) numberK003323
Submission
- Device name
- Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205
- Applicant
- Davol, Inc.
Cranston, RI, US - Received
- October 24, 2000
- Decision date
- January 22, 2001
- 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 |
|---|---|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special | 06/12/2025SE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional | 04/09/2025SE |
| K031213 | Aquasens Fluid Monitoring SystemHIG · Traditional | 04/30/2003SE |
| K030307 | Davol Arthrovent Outflow TubingHRX · Traditional | 02/13/2003SE |
| K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002…GCJ · Traditional | 12/22/2000SE |
| K931899 | Davol AtsCAC · Traditional | 11/15/1994SE |
| K941334 | Davol Laparoscopic Suction Irrigation ProbeHET · Traditional | 06/14/1994SE |
| K921405 | Davol Suction/Irrigator W/ Interchangeable TipHFG · Traditional | 03/25/1994SE |
| K935503 | Davol Laparoscopic Insufflation Tubing SetHIF · Traditional | 03/07/1994SE |
| K926479 | Bard Laparoscopic Irrigator Pump SystemGCJ · Traditional | 03/01/1994SE |
Questions and answers
When was Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 cleared by the FDA?
Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 (K003323) received a 510(k) decision of Substantially Equivalent on January 22, 2001, 90 days after the submission was received.
What is the product code of K003323?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.