# K223256: Optimos™ Cystotome

- Pathway: 510(k) (Traditional)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Apr 5, 2023 after 166 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K970053 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022595: Wilson-Cook Cystotome, Wilson-Cook Medical, Inc. (2002) Summary page 5.

## Indications for use
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Source page: https://510kreport.com/device/K223256
Methodology: https://510kreport.com/methodology