BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
FDA 510(k) clearance K991637 · decided 1999-06-22
Clearance details
- K-number
- K991637
- Device name
- BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-12
- Decision date
- 1999-06-22
- Days to decision
- 41 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
- Canston, RI, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| Parietene™ Macroporous Mesh (PPM5050 ) (K250869) | Sofradim Production | 2025-04-23 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| ProGrip™ Self-Gripping Polypropylene Mesh (K243315) | Sofradim Production | 2025-01-17 |
| 3DMax Light Mesh (K241250) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 |
| Progrip™ Self-Gripping Polypropylene Mesh (K232373) | Sofradim Production | 2024-01-18 |
| Bard 3DMax Mesh (K233402) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Avitene Flowable Collagen Hemostat (N17600/S043) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-06-10 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S044) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-05-20 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S042) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-03-13 |
| AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) (N17600/S041) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-02-18 |
| Avitene Flowable Collagen Hemostat (N17600/S040) | Davol Inc., Sub. C. R. Bard, Inc. | 2024-12-18 |
| Avitene Microfibrillar Collagen Hemostat (MCH) (N17600/S039) | Davol Inc., Sub. C. R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S037) | Davol Inc., Sub. C. R. Bard, Inc. | 2023-10-04 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S038) | Davol Inc., Sub. C. R. Bard, Inc. | 2023-04-25 |