# K962445: Arthrocare Dental Electrosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jul 30, 1996 after 36 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943450 (1995). 4 ancestors in all.
1,325 later devices descend from it; 6 cite it directly.
0 of 1,330 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.
- K950239: Sensimatic 500SE, Parkell, Inc. (1995). Our OCR of the scanned summary read K952039, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Parkell 500SE Sensimatic Electrosurge”.

## Most influential descendants
- K964849: Arthrocare Dermatologic Electrosurgery System (1997), 1,322 descendants of its own
- 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

## Indications for use
The ArthroCare Dental Electrosurgery System is intended for use in dental and periodontal surgical procedures to remove soft tissue and to control bleeding in the oral cavity.

Source page: https://510kreport.com/device/K962445
Methodology: https://510kreport.com/methodology