Single Use Preloaded Sphincterotome V
by Olympus Medical Systems Corp.
510(k) K122505
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122505 | Date11 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K122505
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNS
- Device class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Single Use Preloaded Sphincterotome V is an endoscopic electrosurgical device designed for papillotomy. It is a single-use, preloaded sphincterotome intended for use with high-frequency current in conjunction with an endoscope to incise the sphincter of Oddi during procedures such as endoscopic retrograde cholangiopancreatography (ERCP).
This device is supplied sterile and intended for single-use only. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The KD-VC600 Series is MRI-unsafe due to its metallic components and must be handled with care to avoid contamination. Proper storage involves maintaining sterility until use, adhering to manufacturer guidelines for shelf life, and ensuring compatibility with standard endoscopic systems.