# K242134: ClearCap Distal Attachment

- Pathway: 510(k) (Special)
- Applicant: Finemedix Co., Ltd.
- Decided: Aug 20, 2024 after 29 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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: 2 generations back to K140315 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202616: ClearCap Distal Attachment, Finemedix Co., Ltd. (2021) Summary page 5.

## Indications for use
The ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy. The ClearCap Distal Attachment is intended for the following: » Gastrointestinal mucosal resection (endoscopic mucosal resection) » Keeping the suitable depth of the endoscope’s view field

Source page: https://510kreport.com/device/K242134
Methodology: https://510kreport.com/methodology