# K123061: Ace Monopolar Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Bioeconeer, Inc.
- Decided: Aug 13, 2013 after 316 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: 2 generations back to K945531 (1995). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994075: Geiger Disposable Electrosurgical Electrode, Model 435, Geiger Medical Technologies, Inc. (1999) Summary page 1.

## Most influential descendants
- K150029: Habib EUS RFA (2015), 5 descendants of its own
- K181249: EUSRA RF Electrode (2018), 2 descendants of its own
- K240932: HybridTherm System (2024), 1 descendant of its own
- K161305: Habib EUS RFA (2016), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own

## Indications for use
Thle ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrtosuigical Pencil (mnodel: No.20190-109) ft coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electosurgical Generator (ESU) Systems.

Source page: https://510kreport.com/device/K123061
Methodology: https://510kreport.com/methodology