Chrysalis Intelligence · Sponsors · Davol, Inc.

Davol, Inc.

Warwick, RI, US · 2 510(k) clearances · 10 PMAs · 8 recalls

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Total clearances
2
2025-04-09 → 2025-06-12
Last 12 months
0
Product codes
1
Most recent
2025-06-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FTL Mesh, Surgical, Polymeric Class II General, Plastic Surgery 2 2025-06-12
Class III

PMA approvals (10)

Total PMA records
10
Originals + supplements
Distinct product codes
1
First decision
2020-04-29
Most recent
2026-07-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-15 P050038-S044 Arista™ AH 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2026-04-29 P050038-S043 Arista™ AH 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-11-04 P050038-S042 Arista AH 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-08-09 P050038-S040 Arista AH 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-05-24 P050038-S041 FlexiTip XL-R Applicator 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-10-22 P050038-S038 Arista™ AH Absorbable Hemostatic Particles device 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-08-20 P050038-S039 Arista AH Absorbable Hemostatic Particles Device Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-07-06 P050038-S037 Arista AH Absorbable Hemostatic Particles Normal 180 Day Track No User Fee LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-09-25 P050038-S036 Arista AH Absorbable Hemostatic Special (Immediate Track) LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-04-29 P050038-S035 Arista AH Absorbable Hemostatic Particles Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
Safety

Recalls (8)

Class I (serious)
0
Risk of injury / death
Total recalls
8
Currently ongoing
8
Most recent
2026-03-25
DateSeverityStatusRecall # ProductCodeReason
2026-03-25 Class II Ongoing Z-1896-2026 Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030. — Potential for product to contain foreign matter, confirmed to be inspect fragments.
2023-04-25 Class II Ongoing Z-2244-2023 Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removab… — Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of th…
2023-04-25 Class II Ongoing Z-2243-2023 Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removab… — Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of th…
2023-04-25 Class II Ongoing Z-2242-2023 Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached remov… — Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of th…
2023-04-25 Class II Ongoing Z-2241-2023 Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 — Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of th…
2022-06-27 Class II Ongoing Z-1457-2022 X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) — The device may potentially cause a fire, leading to a safety risk.
2022-06-07 Class II Ongoing Z-1305-2022 HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irr… — The product is not able to provide irrigation.
2022-06-07 Class II Ongoing Z-1304-2022 HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction an… — The product is not able to provide irrigation.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-06-12 K251557 Bard® Mesh; Bard® Mesh Pre-Shaped FTL Class II General, Plastic Surgery
2025-04-09 K250098 Bard Soft Mesh; Bard Soft Mesh Pre-Shaped FTL Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-28 09:33 · Last ingest 2026-07-28T13:32:44.564635 · Pipeline: Chrysalis Intelligence