ARISTA AH ABSORBABLE HEMOSTAT
FDA premarket approval P050038 · decided 2006-09-26
Approval details
- PMA number
- P050038
- Trade name
- ARISTA AH ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Davol, Inc.
- Date received
- 2005-09-30
- Decision date
- 2006-09-26
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- APPROVAL FOR THE ARISTA AH ABSORBABLE HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| AQUASENS FLUID MONITORING SYSTEM (K031213) | Davol, Inc. | 2003-04-30 |
| DAVOL ARTHROVENT OUTFLOW TUBING (K030307) | Davol, Inc. | 2003-02-13 |
| COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (K003323) | Davol, Inc. | 2001-01-22 |
| DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 (K003790) | Davol, Inc. | 2000-12-22 |
| DAVOL ATS (K931899) | Davol, Inc. | 1994-11-15 |
| DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (K941334) | Davol, Inc. | 1994-06-14 |