# K153773: Disposal Lens Cleaning Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Nov 22, 2016 after 327 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904871 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045, Minimally Invasive Devices, LLC (2008) Summary page 5.

## Indications for use
The Disposable Lens Cleaning Sheath is an endoscope accessory that uses saline solution and carbon dioxide to remove debris from the lens surface of endoscopes used within the thoracic and abdominal cavities, including female reproductive organs

Source page: https://510kreport.com/device/K153773
Methodology: https://510kreport.com/methodology