# K050161: System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy

- Pathway: 510(k) (Special)
- Applicant: Conmed Electrosurgery
- Decided: Feb 3, 2005 after 9 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: 1 generation back to K981220 (1998). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981220: System 7500 Abc Electrosurgical Unit, Aspen Laboratories, Inc. (1998) Summary page 1.
- K990586: Conmed Abc Probe for Flexible Endoscopes, Conmedcorp (1999) Summary page 1.

## Most influential descendants
- K152860: Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile Pedestal (2015), 3 descendants of its own
- K172671: HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal (2017), 2 descendants of its own
- K213354: Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart (2022), 0 descendants of its own
- K203522: Surn5 Electrosurgical Argon Beam Generator and Accessories (2021), 0 descendants of its own

## Indications for use
The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFIeX TM Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.

Source page: https://510kreport.com/device/K050161
Methodology: https://510kreport.com/methodology