# K020711: Wallach Loop Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Jun 3, 2002 after 90 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: 1 generation back to K932102 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944433: Surgi-Link Electrosurgical Electrode, Unimed Surgical Products, Inc. (1994) Summary page 1.
- K932102: Electrosurgical Electrode, Megadyne Medical Products, Inc. (1993) Summary page 1.

## Most influential descendants
- K070275: Flexible Loop Electrosurgical Electrode (2007), 0 descendants of its own

## Recalls of this device
- Apr 30, 2021 · Class II · Z-1847-2021: The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.

## Indications for use
Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.

Source page: https://510kreport.com/device/K020711
Methodology: https://510kreport.com/methodology