# K955247: Olympus KD Series Sphincterotome

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Apr 30, 1996 after 167 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Olympus KD-1/2 pre-Amendment Diathermic Cutters: named in the summary without a submission number
- (no number) Olympus PK Papillotomy Knives: named in the summary without a submission number
- (no number) Olympus KD-6G Sphincterotomes: named in the summary without a submission number

## Most influential descendants
- K971328: Olympus CD-6C-1 Coagulation Electrode (1997), 4 descendants of its own
- K120909: EC 2.7 Endoscopic Cutter (2012), 3 descendants of its own
- K183240: Empower RF Catheter (2019), 1 descendant of its own
- K200702: EasyPath RF Introducer Sheath (2021), 0 descendants of its own
- K170296: CoreCath 2.7S (2017), 0 descendants of its own

## Indications for use
The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater

Source page: https://510kreport.com/device/K955247
Methodology: https://510kreport.com/methodology