ArthroCare Corporation
ArthroCare Corporation holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 5 FDA device recalls on record.
Top product codes for ArthroCare Corporation
FDA recalls by ArthroCare Corporation
- Z-2999-2020 — Speed Stitch Needle Cassette
- Z-3000-2020 — Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
- Z-1321-2016 — TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
- Z-0623-2016 — Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
- Z-2105-2015 — EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by ArthroCare Corporation
- K254122 — FLOW FLEXTEND Wand (72290039)
- K253680 — LYNX COBLATION Laryngeal Wand (72290254)
- K240964 — FLOW 90? Wand
- K232290 — INTELLIO SHIFT System
- K230914 — ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113) +2 more
- K220563 — Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
- K210423 — Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
- K202006 — ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
- K192027 — WEREWOLF COBLATION System, COBLATION HALO Wand
- K183346 — FLOW 90 Wand
- K180848 — AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
- K172165 — Q-Fix Suture Anchor
- K163142 — SpeedStitch Suture Passer +2 more
- K161481 — Ambient HipVac 50 Wand with Integrated Finger Switches
- K162126 — Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)
- K162074 — Werewolf RF20000 Controller, FLOW 50 Wand
- K153675 — Paragon T2 Wand with Integrated Cable
- K153313 — SpeedLock Knotless Fixation System
- K143235 — RF20000a Controller, FLOW 50 Wand
- K151897 — MultiFIX® P Knotless Fixation Device
- K151660 — MultiFIX S Knotless Fixation System
- K142999 — EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
- K140992 — ARTHROCARE NASASTENT CMC NASAL DRESSING
- K140521 — TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
- K140604 — MULTIFIX S KNOTLESS FIXATION SYSTEM
- K133606 — N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
- K133727 — Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU
- K132513 — Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
- K132590 — 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
- K132099 — ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
- K131205 — ARTHROCARE HEAD AND NECK COBLATION WAND
- K122652 — ARTHROCARE TURBINATOR WAND
- K123353 — CIQ CONTROLLER, CIQ WANDS
- K123240 — SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
- K120943 — SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
- K120096 — MULTIFIX P KNOTLESS FIXATION DEVICE
- K111044 — SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.