# K030108: Arthrocare Ent Coblator Surgery System

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Feb 3, 2003 after 21 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 53 ancestors in all.
92 later devices descend from it; 6 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021364: Modification to Entec Plasma Wands, Arthrocare Corp. (2002)

## Most influential descendants
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K033257: Arthrocare Ent Plasma Wands (2003), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own

## Recalls of this device
- Feb 20, 2015 · Class II · Z-1323-2015: The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).

## Indications for use
The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: Adenoidectomy CY- Head, Neck, Oral, and Sinus Surgery Mastoidectomy Myringotomy with Effective Hemorrhage Control Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates NasopharyngeaKaryngeaI indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking Neck Mass Papilloma Keloids Submucosal Palatal Shrinkage Submucosal Tissue Shrinkage Tonsillectomy Traditional Uvulopalatoplasty (RAUP) Tumors Tissue in the UvuldSoft Palate for the Treatment of Snoring

Source page: https://510kreport.com/device/K030108
Methodology: https://510kreport.com/methodology