# K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Sep 17, 1999 after 284 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853585 (1986). 3 ancestors in all.
30 later devices descend from it; 7 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 4.

## Most influential descendants
- K070330: Third Eye Retroscope Auxiliary Endoscopy System (2007), 13 descendants of its own
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K083180: Third Eye Retroscope Auxiliary Endoscopy System (2009), 5 descendants of its own
- K122565: Arc Endocuff (2012), 4 descendants of its own

## Recalls of this device
- Jul 27, 2023 · Class II · Z-2522-2023: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
- Jul 27, 2023 · Class II · Z-2523-2023: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

## Indications for use
The Olympus Distal Attachment is intended to be used for the following: a) for use with electrosurgical snares for endoscopic mucosal resection within the gastrointestinal tract; and b) for use in keeping the suitable depth of endoscopic field of view.

Source page: https://510kreport.com/device/K984358
Methodology: https://510kreport.com/methodology