# K982130: Return Electrode Clamp Shell Cord Model RC 201

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics, Ltd.
- Decided: Aug 7, 1998 after 51 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 22, 2010 · Not classified · Z-1142-2010: Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M.

## Indications for use
Electrosurgery accessory. Patient return electrode conductor cable for use with the Valleylab E7509 and similar return electrode monitor compatible patient return electrodes that do not have integral cords.

Source page: https://510kreport.com/device/K982130
Methodology: https://510kreport.com/methodology