# K012631: Reprocessed Soft Tissue Ablators

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Dec 6, 2001 after 115 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: 7 generations back to K943450 (1995). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000036: Entec Reflex Wand 55, Model E4055-00, Arthrocare Corp. (2000) Summary page 2.
- K000044: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spinewands, Arthrocare Corp. (2000) Summary page 2.
- K000074: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Plasma Scalpel GS, Turbovac GS, Arthrocare Corp. (2000) Summary page 2.
- K000228: Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand, Arthrocare Corp. (2000) Summary page 2.
- K000511: Modification to Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spine Wands, Arthrocare Corp. (2000) Summary page 2.
- K000936: Vapr 2.3MM Wedge Electrode for Use with Vapr System, Mitek Products (2000) Summary page 2.
- K001302: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Plasma Scalpel GS, C, Arthrocare Corp. (2000) Summary page 2.
- K001936: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Corp. (2000) Summary page 2.
- K943450: Arthrocare Arthroscopic Electrosurgery System Model 970, Arthrocare Corp. (1995) Summary page 2.
- K955531: Arthrocare Bipolar Loop Electrode System, Arthrocare Corp. (1996) Summary page 2.
- K961069: Arthrocare Urologic Multi-Electrode Electrosurgery System, Arthrocare Corp. (1996). Our OCR of the scanned summary read K960169, FDA’s number for Carbomedics Valve Tester (Carbomedics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ArthroCare® Urologic Multi-electrode Electrosurgery System”.
- K962445: Arthrocare Dental Electrosurgery System, Arthrocare Corp. (1996) Summary page 2.
- K963123: Arthrocare Arthroscopic Eletrosurgery System (Model 980), Arthrocare Corp. (1996) Summary page 2.
- K963783: Mitek Electrosurgical System for Arthroscopic Use, ETHICON, Inc. (1996) Summary page 2.
- K964849: Arthrocare Dermatologic Electrosurgery System, Arthrocare Corp. (1997) Summary page 2.
- K971532: Arthrocare Electrosurgery System, Arthrocare Corp. (1997) Summary page 2.
- K973478: Arthrocare Sinus Electrosurgery System, Arthrocare Corp. (1998) Summary page 2.
- K974022: VAPR, Mitek Products (1998) Summary page 2.
- K981870: Visage Cosmetic Surgery System, Arthrocare Corp. (1998) Summary page 2.
- K992180: Visage Cosmetic Surgery, Model V5000, Arthrocare Corp. (2000) Summary page 2.
- K992406: Vapr 2.3MM End Effect Electrode for Use with Vapr System, Mitek Products (1999) Summary page 2.
- K992581: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands, Arthrocare Corp. (1999) Summary page 2.
- K992972: Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Electrosurgery Wand, Models H2000, Arthrocare Corp. (1999) Summary page 2.

## Most influential descendants
- K052692: Suretek Medical Reprocessed Electrosurgical Electrodes (2006), 0 descendants of its own

## Indications for use
Reprocessed soft tissue ablators are to be used in patients requiring arthroscopic surgery of the knee, shoulder, ankle, hip, wrist and elbow to resect, ablate and excise soft tissue.

Source page: https://510kreport.com/device/K012631
Methodology: https://510kreport.com/methodology