# K173004: SB Soft Hood - Straight type, SB Soft Hood - Undercut type

- Pathway: 510(k) (Traditional)
- Applicant: Sumitomo Bakelite Co., Ltd.
- Decided: May 8, 2018 after 223 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.
No later device cites it as a predicate yet.
0 of 5 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 4.

## Indications for use
SB Soft Hood is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and for use in keeping the suitable depth of endoscopic field of view.

Source page: https://510kreport.com/device/K173004
Methodology: https://510kreport.com/methodology