# K943629: Gip/Medi-Globe Papillotome

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corp.
- Decided: May 26, 1995 after 304 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061684: Medi-Globe Rota-Cut Sphincterotome (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K943629
Methodology: https://510kreport.com/methodology