# K973826: Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 5, 1997 after 59 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. The FDA summary names its predicate without a number.
- (no number) Microvasive® Rapid Exchange Sphincterotome: named in the summary without a submission number
- (no number) Ultratome XL™ Triple Lumen Sphincterotome: named in the summary without a submission number

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

## Indications for use
The Microvasive® Needle Knife Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive Needle Knife can also be used to cannulate and inject contrast medium.

Source page: https://510kreport.com/device/K973826
Methodology: https://510kreport.com/methodology