COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
FDA 510(k) clearance K003323 · decided 2001-01-22
Clearance details
- K-number
- K003323
- Device name
- COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
- Applicant
- Davol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-24
- Decision date
- 2001-01-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FTL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cranston, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 00 recall (Z-0359-2007) | Davol, Inc., Sub. C. R. Bard, Inc. | 2007-01-30 |
| Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204 recall (Z-0360-2007) | Davol, Inc., Sub. C. R. Bard, Inc. | 2007-01-30 |
| Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206 recall (Z-0524-06) | Davol, Inc., Sub. C. R. Bard, Inc. | 2006-02-22 |
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| Record | Firm | Date |
|---|---|---|
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| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
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| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |