ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R
FDA premarket approval P050038/S023 · decided 2015-03-16
Approval details
- PMA number
- P050038
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Davol, Inc.
- Date received
- 2014-07-29
- Decision date
- 2015-03-16
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- APPROVAL FOR THE LINE EXTENSION OF THE FLEXITIP XL APPLICATOR FAMILY TO INCLUDE THE FLEXITIP XL-R APPLICATOR. THE MODIFICATION IS BASED UPON THE CURRENT APPLICATOR DESIGN BUT NOW INCLUDES AN ADDITIONAL OUTER STAINLESS STEEL TUBING TO CREATE A RIGID (XL-R) PORTION OF THE APPLICATOR TIP. IN ADDITION, APPROVAL FOR REVISION OF THE INSTRUCTIONS FOR USE OF THE ARISTA AH PRODUCT LABELING IN ORDER TO INFORM USERS OF USE OF THE NEW APPLICATOR DURING ENDOSCOPIC/ LAPAROSCOPIC USES.
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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 |