# K110189: Reprocessed Electrosurgical Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Jul 18, 2011 after 175 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- 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 K910831 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012700: Vanguard Reprocessed Endoscopic Instruments, Vanguard Medical Concepts, Inc. (2001) Summary page 1.
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.

## Indications for use
Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue. The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.

Source page: https://510kreport.com/device/K110189
Methodology: https://510kreport.com/methodology