510(k) Report

FDA applicant

Arthrocare Corp.

Sunnyvale, CA149 decisions1995–202630 recalls

FDA records 149 decisions for Arthrocare Corp. (Sunnyvale, CA) from 1995 to 2026: 149 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 242 predicates, 183 of them its own earlier devices. 30 recalls are linked to its devices.

FDA’s records also spell it “ArthroCare Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Arthrocare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 112008: 92009: 82010: 82011: 62012: 22013: 92014: 62015: 42016: 52017: 22018: 12019: 22020: 12021: 12022: 12023: 22024: 12026 (partial year): 2
2007high 11 (2007) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2020

2008: 32010: 12011: 182014: 12015: 52016: 12020: 1
2007high 18 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Arthrocare Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arthrocare Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories86decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue31decisions
  • HRXArthroscope7decisions
  • NDNCement, Bone, Vertebroplasty6decisions
  • FASElectrode, Electrosurgical, Active, Urological5decisions
  • HWCScrew, Fixation, Bone4decisions

Also: OCW (2), LYA (1), GAT (1), GXI (1), OAR (1), EKZ (1).

How long do its 510(k) reviews take?

Since 2016, its 18 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 12 of its 18 were faster than that.

Whose devices does it build on?

Its devices cite 242 predicates; 183 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 307 times; 183 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 199511cite it
  • K070374Arthrocare Ent Plasma WandArthrocare Corp. · 20079cite it
  • K083306Modification to Arthrocare ArthrowandsArthrocare Corp. · 20088cite it
  • K001588Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch…Arthrocare Corp. · 20008cite it
  • K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 19977cite it
  • K014290Entec Plasma WandsArthrocare Corp. · 20027cite it

What has FDA decided for it lately?

  • K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
  • K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · 2026
  • K240964FLOW 90? WandArthroCare Corporation · 2024
  • K232290INTELLIO SHIFT SystemArthroCare Corporation · 2023
  • K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+…ArthroCare Corporation · 2023
  • K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System…ArthroCare Corporation · 2022
  • K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandArthroCare Corporation · 2021
  • K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation…ArthroCare Corporation · 2020

All 112 as Arthrocare Corp. →All 37 as ArthroCare Corporation →

What has been recalled?

30 recalls linked to its devices; the latest:

  • K163142Speed Stitch Needle CassetteAug 17, 2020Class II
  • K080282TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01…Mar 3, 2016Class II
  • K063172Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft…Oct 26, 2015Class II
  • K070374EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product…Jun 2, 2015Class II
  • K142999EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices…May 15, 2015Class II
  • K142999PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices…May 15, 2015Class II