Chrysalis Intelligence · Sponsors · ArthroCare Corporation

ArthroCare Corporation

Austin, TX, US · 8 510(k) clearances · 1 recalls

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Total clearances
8
2020-12-18 → 2026-03-30
Last 12 months
2
Product codes
1
Most recent
2026-03-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 8 2026-03-30
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2020-08-17
DateSeverityStatusRecall # ProductCodeReason
2020-08-17 Class II Ongoing Z-2999-2020 Speed Stitch Needle Cassette — Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as oppo…
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-03-30 K254122 FLOW FLEXTEND Wand (72290039) GEI Class II General, Plastic Surgery
2026-03-25 K253680 LYNX COBLATION Laryngeal Wand (72290254) GEI Class II General, Plastic Surgery
2024-05-08 K240964 FLOW 90? Wand GEI Class II General, Plastic Surgery
2023-12-11 K232290 INTELLIO SHIFT System GEI Class II General, Plastic Surgery
2023-06-26 K230914 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) GEI Class II General, Plastic Surgery
2022-09-01 K220563 Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System GEI Class II General, Plastic Surgery
2021-06-24 K210423 Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand GEI Class II General, Plastic Surgery
2020-12-18 K202006 ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System GEI Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence