# K012640: Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands

- Pathway: 510(k) (Traditional)
- Applicant: Medical Instruments Technology, Inc.
- Decided: Feb 28, 2002 after 199 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943450 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974022: VAPR, Mitek Products (1998) Summary page 1.
- K962321: Arthocare Arthroscopic Electrosurgery System Model 970, Arthrocare Corp. (1996) Summary page 1.

## Recalls of this device
- Mar 11, 2008 · Not classified · Z-1680-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

## Indications for use
MIT’s unique reprocessing of the wands does not change their intended use. The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.

Source page: https://510kreport.com/device/K012640
Methodology: https://510kreport.com/methodology