# K061684: Medi-Globe Rota-Cut Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corporation
- Decided: Jun 27, 2006 after 12 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
Longest line of descent: 3 generations back to K970053 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943629: Gip/Medi-Globe Papillotome, Medi-Globe Corp. (1995) Summary page 1.
- K973826: Sphincterotome, Boston Scientific Corp (1997) Summary page 1.
- K013153: Autotome RX Model # 4515, 4516, Boston Scientific Corp (2001) Summary page 1.
- K972674: Wilson-Cook Needle Knife Papillotome, Wilson-Cook Medical, Inc. (1997) Summary page 1.
- K033203: Wilson-Cook Tri-Tome Select Plus, Wilson-Cook Medical, Inc. (2003) Summary page 1.

## Indications for use
The Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.

Source page: https://510kreport.com/device/K061684
Methodology: https://510kreport.com/methodology