# K202616: ClearCap Distal Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Feb 19, 2021 after 163 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: 1 generation back to K140315 (2014). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140315: US Endoscopy Distal Attachment Cap, United States Endoscopy Group, Inc. (2014) Summary page 4.

## Most influential descendants
- K260423: Disposable Endoscopic Distal Attachments (2026), 0 descendants of its own
- K242134: ClearCap Distal Attachment (2024), 0 descendants of its own

## 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/K202616
Methodology: https://510kreport.com/methodology