# K981220: System 7500 Abc Electrosurgical Unit

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Laboratories, Inc.
- Decided: Apr 21, 1998 after 18 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
No predicates in its family tree.
6 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050161: System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible Endoscopy (2005), 4 descendants of its own
- 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
Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

Source page: https://510kreport.com/device/K981220
Methodology: https://510kreport.com/methodology