# K971532: Arthrocare Electrosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jul 23, 1997 after 86 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). 11 ancestors in all.
1,029 later devices descend from it; 7 cite it directly.
0 of 1,041 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.
- 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.
- K962445: Arthrocare Dental Electrosurgery System, Arthrocare Corp. (1996) Summary page 1.
- K963123: Arthrocare Arthroscopic Eletrosurgery System (Model 980), Arthrocare Corp. (1996) Summary page 1.
- K964849: Arthrocare Dermatologic Electrosurgery System, Arthrocare Corp. (1997) Summary page 1.
- K800617: Hyfrecator, #733, Birtcher Corp. (1980) Summary page 1.
- K850668: Electrosurgical Unit 774, Birtcher Corp. (1985) Summary page 1.

## Most influential descendants
- K974521: Vnus Closure System (1998), 977 descendants of its own
- K982816: Vnus Closure System (1999), 973 descendants of its own
- K012398: Diomed 15 Diode Laser (2002), 714 descendants of its own
- K022266: Aurora SR (2002), 705 descendants of its own
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own

## Indications for use
The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.

Source page: https://510kreport.com/device/K971532
Methodology: https://510kreport.com/methodology