# K140624: Hicura Hand Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Dec 10, 2014 after 274 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: 3 generations back to K945975 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K944201: HI-Q Hand Instruments- Urology, Olympus America, Inc. (1994) Summary page 5.
- K984417: Bipolar Grasping Forceps  Biq+, Olympus America, Inc. (1999) Summary page 5.

## Indications for use
The Olympus hand instruments are specifically designed for endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavity.

Source page: https://510kreport.com/device/K140624
Methodology: https://510kreport.com/methodology