Model: ECK19-30-05-200
DI: 06934415024570
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Disposable Sphincterotome
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a2a3ce2b-32ff-49fa-8499-5c1c4971c99a
Distribution Status:
In Commercial Distribution
DUNS Number:
542947117
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06934415024570
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65185
Name: ERCP catheter, non-balloon, electrosurgical
Definition:
A flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device.
FDA Product Codes
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Premarket Submissions
Submission Number:
K242192
Supplement Number:
000