# K160053: Monopolar single-use HF cable

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: May 6, 2016 after 116 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 K944200 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944200: HI-Q Hand Instruments, OB/Gyn Use, Olympus America, Inc. (1995) Summary page 5.

## Cited in the summary but kept off the family tree
- K890328: Adult Resectoscope, Circon Video (1990). Our reading of the summary gave K890328, FDA’s number for Adult Resectoscope (Circon Video). Its FDA name has none of the distinctive words the summary uses for the device it names, “Disposable Active Cord”. Kept off the family tree. Summary page 5.

## Indications for use
HF cable for electrotherapeutical use in endoscopic procedures in conjunction with compatible active accessories and compatible electrosurgical units.

Source page: https://510kreport.com/device/K160053
Methodology: https://510kreport.com/methodology