# K243388: Disposable Distal Cap

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Jun 27, 2025 after 239 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- 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: 3 generations back to K853585 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597, Olympus America, Inc. (1999) Summary page 5.

## Most influential descendants
- K253139: Disposable Distal Cap (2026), 0 descendants of its own

## Indications for use
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.

Source page: https://510kreport.com/device/K243388
Methodology: https://510kreport.com/methodology