# K973478: Arthrocare Sinus Electrosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jan 9, 1998 after 116 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 4 generations back to K943450 (1995). 14 ancestors in all.
1,219 later devices descend from it; 6 cite it directly.
0 of 1,234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943450: Arthrocare Arthroscopic Electrosurgery System Model 970, Arthrocare Corp. (1995) Summary page 1.
- K963123: Arthrocare Arthroscopic Eletrosurgery System (Model 980), Arthrocare Corp. (1996) Summary page 1.
- K962445: Arthrocare Dental Electrosurgery System, Arthrocare Corp. (1996) Summary page 1.
- K964849: Arthrocare Dermatologic Electrosurgery System, Arthrocare Corp. (1997) Summary page 1.
- K952681: Stryker Hummer II Microdebrider System, Stryker Endoscopy (1995) Summary page 1.
- K921884: FORCE 2, Valleylab, Inc. (1992) Summary page 1.
- K914136: Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase, Coherent Medical Group (1992) Summary page 1.
- K933362: Sharplan CO2 Surgical Laser, Laser Industries, Ltd. (1994) Summary page 1.

## Most influential descendants
- K981870: Visage Cosmetic Surgery System (1998), 1,073 descendants of its own
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own
- K013034: Modification to: Thermacool Iia (2001), 800 descendants of its own
- K013639: Thermage Thermacool TC System (2002), 799 descendants of its own
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own

## Indications for use
The AccENT Head and Neck Electrosurgery System is indicated for ablation and coagulation of soft tissue in otolaryngological (ENT) surgery including head, neck, oral, and sinus surgery.

Source page: https://510kreport.com/device/K973478
Methodology: https://510kreport.com/methodology