# K964849: Arthrocare Dermatologic Electrosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Apr 14, 1997 after 132 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: 3 generations back to K943450 (1995). 6 ancestors in all.
1,322 later devices descend from it; 5 cite it directly.
0 of 1,329 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.
- K962445: Arthrocare Dental Electrosurgery System, Arthrocare Corp. (1996) Summary page 1.
- K955531: Arthrocare Bipolar Loop Electrode System, Arthrocare Corp. (1996) Summary page 1.
- K961069: Arthrocare Urologic Multi-Electrode Electrosurgery System, Arthrocare Corp. (1996) Summary page 1.
- K800617: Hyfrecator, #733, Birtcher Corp. (1980) Summary page 1.

## Most influential descendants
- K973478: Arthrocare Sinus Electrosurgery System (1998), 1,219 descendants of its own
- K981870: Visage Cosmetic Surgery System (1998), 1,073 descendants of its own
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own
- K971532: Arthrocare Electrosurgery System (1997), 1,029 descendants of its own
- K974521: Vnus Closure System (1998), 977 descendants of its own

## Indications for use
The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.

Source page: https://510kreport.com/device/K964849
Methodology: https://510kreport.com/methodology