# K172647: Reprocessed ArthroCare ENT Coblator

- Pathway: 510(k) (Traditional)
- Applicant: Renovo, Inc.
- Decided: Feb 21, 2018 after 173 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K936109 (1994). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142999: EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable, ArthroCare Corporation (2014) Summary page 4.
- K070374: Arthrocare Ent Plasma Wand, Arthrocare Corp. (2007) Summary page 4.

## Indications for use
The Reprocessed ArthroCare ENT Coblators 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 by 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 - Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Source page: https://510kreport.com/device/K172647
Methodology: https://510kreport.com/methodology