# Arthrocare Corp.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 149 (1995–2026): 149 510(k) clearances
- Names in FDA's records: Arthrocare Corp. (112); ArthroCare Corporation (37)
- Product codes: GEI (86), MBI (31), HRX (7), NDN (6), FAS (5), HWC (4), OCW (2), LYA (1), GAT (1), GXI (1), OAR (1), EKZ (1)
- 510(k) review time since 2016: median 87 days, against 107 for FDA's reviews in the same codes and years (12 of 18 faster)
- Predicates its devices cite: 242 (183 its own); citations of its devices by later devices: 307 (183 its own)
- Recalls linked to its devices: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 9 (https://510kreport.com/company/arthrex)
- Opus Medical, Inc.: 7 (https://510kreport.com/company/opus-medical)
- Birtcher Corp.: 4 (https://510kreport.com/company/birtcher)
- ETHICON, Inc.: 3 (https://510kreport.com/company/ethicon)
- Ellman Intl., Inc.: 3 (https://510kreport.com/company/ellman-intl)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Arthocare Corporation: 2 (https://510kreport.com/company/arthocare)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Alliance Medical Corp.: 19 (https://510kreport.com/company/alliance-medical)
- Renovo, Inc.: 14 (https://510kreport.com/company/renovo)
- Stryker Endoscopy: 9 (https://510kreport.com/company/stryker-endoscopy)
- Smith & Nephew, Inc.: 6 (https://510kreport.com/company/smith-nephew)
- Arthocare Corporation: 6 (https://510kreport.com/company/arthocare)
- Gyrus Ent LLC: 6 (https://510kreport.com/company/gyrus-ent)
- U&I Corporation: 4 (https://510kreport.com/company/u-i)
- Medisiss: 4 (https://510kreport.com/company/medisiss)

## Its most-cited devices
- K943450: Arthrocare Arthroscopic Electrosurgery System Model 970 (1995), cited by 11
- K070374: Arthrocare Ent Plasma Wand (2007), cited by 9
- K083306: Modification to Arthrocare Arthrowands (2008), cited by 8
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20 (2000), cited by 8
- K971532: Arthrocare Electrosurgery System (1997), cited by 7
- K014290: Entec Plasma Wands (2002), cited by 7

## Recent decisions
- K254122: FLOW FLEXTEND Wand (72290039) (Mar 30, 2026)
- K253680: LYNX COBLATION Laryngeal Wand (72290254) (Mar 25, 2026)
- K240964: FLOW 90? Wand (May 8, 2024)
- K232290: INTELLIO SHIFT System (Dec 11, 2023)
- K230914: ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) (Jun 26, 2023)
- K220563: Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System (Sep 1, 2022)
- K210423: Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand (Jun 24, 2021)
- K202006: ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System (Dec 18, 2020)

Source page: https://510kreport.com/company/arthrocare