Endoscope Introducer Kit
by Mitsubishi Cable America, Inc.
510(k) K955717
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955717 | Date18 Apr 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FDE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Endoscope Introducer Kit is a medical device designed for laparoscopic choledochoscopy, providing an access channel for the insertion of small-diameter endoscopes. It facilitates minimally invasive procedures by enabling controlled passage of endoscopic instruments through a protected pathway.
The kit includes an internal dilator with a luer fitting and an external sheath equipped with a hemostasis valve and luer fitting, ensuring sterility and ease of use. Supplied as a single-use device, it is intended for use in sterile surgical settings and has received FDA 510(k) clearance under the classification of Class II medical devices. The device adheres to regulatory standards for laparoscopic instruments and is authorized for distribution in the United States.
Other devices from Mitsubishi Cable America, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Endoscope Introducer Kit primarily used for in surgical procedures?
The Endoscope Introducer Kit is designed specifically for laparoscopic choledochoscopy, providing a protected access channel to insert small-diameter endoscopes. It enables minimally invasive procedures by allowing controlled passage of endoscopic instruments through the sheath, reducing the risk of contamination or trauma during insertion.
Is the Endoscope Introducer Kit intended for reuse, or is it meant to be used only once?
The Endoscope Introducer Kit is explicitly labeled as a single-use device. This ensures sterility and safety in sterile surgical settings, as reuse could compromise the integrity of the sheath and dilator, potentially leading to contamination or procedural complications.
What features does the kit include to ensure ease of use during laparoscopic procedures?
The kit includes an internal dilator with a luer fitting and an external sheath equipped with a hemostasis valve and luer fitting. These components work together to facilitate controlled insertion of endoscopes while maintaining sterility and preventing fluid leakage during the procedure.
How is the regulatory status of this device determined, and what does that mean for purchasing or use in the U.S.?
The Endoscope Introducer Kit has received FDA 510(k) clearance under the classification of Class II medical devices, meaning it has been determined to be substantially equivalent to a legally marketed device. This clearance allows for distribution in the United States, ensuring it meets regulatory standards for safety and effectiveness as intended for laparoscopic choledochoscopy.
What specialties are most likely to use this device, and why?
The device is primarily associated with the specialties of gastroenterology and urology, as indicated by its regulatory submissions. It is designed for laparoscopic choledochoscopy, a procedure commonly performed by gastroenterologists to examine the bile ducts, while its use in urology may extend to similar minimally invasive endoscopic applications requiring controlled access.