ArthroCare Corporation
FDA Regulatory Profile
ArthroCare Corporation appears in FDA public data with 5 recalls, 37 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2999-2020, Class II) was initiated on August 17, 2020. Its most recent 510(k) clearance was granted on March 30, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 37
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2999-2020 | Class II | Speed Stitch Needle Cassette | August 17, 2020 |
| Z-3000-2020 | Class II | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 008174700069 | February 21, 2019 |
| Z-1321-2016 | Class II | TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ Micro | March 3, 2016 |
| Z-0623-2016 | Class II | Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hem | October 26, 2015 |
| Z-2105-2015 | Class II | EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLAS | June 2, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254122 | FLOW FLEXTEND Wand (72290039) | March 30, 2026 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | March 25, 2026 |
| K240964 | FLOW 90? Wand | May 8, 2024 |
| K232290 | INTELLIO SHIFT System | December 11, 2023 |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF | June 26, 2023 |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION | September 1, 2022 |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | June 24, 2021 |
| K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Cobl | December 18, 2020 |
| K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | December 20, 2019 |
| K183346 | FLOW 90 Wand | January 24, 2019 |
| K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | May 1, 2018 |
| K172165 | Q-Fix Suture Anchor | August 17, 2017 |
| K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, | January 6, 2017 |
| K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches | October 21, 2016 |
| K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KV | September 29, 2016 |
| K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | August 22, 2016 |
| K153675 | Paragon T2 Wand with Integrated Cable | January 15, 2016 |
| K153313 | SpeedLock Knotless Fixation System | December 11, 2015 |
| K143235 | RF20000a Controller, FLOW 50 Wand | October 23, 2015 |
| K151897 | MultiFIX® P Knotless Fixation Device | August 6, 2015 |