# K101592: Erase Hand- Held Controller; Erase Single Use Electric Catridge System

- Pathway: 510(k) (Traditional)
- Applicant: Cheng Medical, Corporation
- Decided: Oct 6, 2011 after 486 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982489 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982489: RFG-3C Plus, Radionics, Inc. (1998) Summary page 2.

## Indications for use
The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions, in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.

Source page: https://510kreport.com/device/K101592
Methodology: https://510kreport.com/methodology