# K012679: Reprocessed RF Arthroscopy Probes

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 8, 2001 after 86 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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: 6 generations back to K943450 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992581: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands, Arthrocare Corp. (1999) Summary page 1.
- K991140: Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System and Accessories, Oratec Interventions, Inc. (1999) Summary page 1.
- K974022: VAPR, Mitek Products (1998) Summary page 1.
- K992876: Vapr 2.3 MM Side Effect Electrode for Use with Vapr System, Mitek Products (1999) Summary page 1.
- K002422: Varpr 3.5MM 90 Suction Electrode for Use with Vapr System, Mitek Products (2000) Summary page 1.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0568-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
These devices are designed for general surgical use, including orthopedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissue. Arthroscopic surgery may include: Knee Shoulder Ankle Elbow Wrist

Source page: https://510kreport.com/device/K012679
Methodology: https://510kreport.com/methodology