# K173400: ORISE Tissue Retractor System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Feb 9, 2018 after 101 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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 K040836 (2004). 3 ancestors in all.
2 later devices descend 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)
- K153698: LumenR Tissue Retractor System, Lumenr, LLC (2016) Summary page 4.

## Most influential descendants
- K182540: DiLumen Endolumenal Interventional Platform (2018), 1 descendant of its own
- K210851: DiLumen Endolumenal Interventional Platform (DiLumen) (2021), 0 descendants of its own

## Indications for use
This device is indicated for use in conjunction with an endoscope in the gastrointestinal tract for tissue or foreign body manipulation and/or where multiple removal and insertions of an endoscope are required.

Source page: https://510kreport.com/device/K173400
Methodology: https://510kreport.com/methodology