DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES
FDA 510(k) clearance K936102 · decided 1994-05-17
Clearance details
- K-number
- K936102
- Device name
- DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-22
- Decision date
- 1994-05-17
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cranston, RI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |