Da Vinci Cholangiogram Delivery Device
by Da Vinci Medical, Inc. 510(k)
Active
510(k) K934739
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934739 | Date23 Dec 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Davinci Cholangiogram Delivery Device
- 510(k) Number
- FDA Product Code
- GCJ
- 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 Da Vinci Cholangiogram Delivery Device is a medical instrument classified under the nomenclature for biliary and pancreatic diagnostic devices. It is designed to facilitate the delivery of contrast media during cholangiography, a procedure used to visualize the bile ducts and gallbladder via fluoroscopy or X-ray imaging.
This device is intended for use in radiology or endoscopy settings and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K934739) and falls under the product code GCJ, with a decision date of December 23, 1993. No third-party review was involved in its clearance process.
Other devices from Da Vinci Medical, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Da Vinci Cholangiogram Delivery Device in a clinical setting?
The Da Vinci Cholangiogram Delivery Device is specifically designed to assist in delivering contrast media during cholangiography procedures. This helps radiologists or endoscopists visualize the bile ducts and gallbladder using fluoroscopy or X-ray imaging, enabling better diagnostic assessment of biliary or pancreatic conditions.
Is the Da Vinci Cholangiogram Delivery Device intended for reuse or is it single-use?
The device is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of contamination or cross-infection, which is critical in procedures involving the biliary system.
Where would this device typically be used, and what type of facility would require it?
This device is designed for use in radiology or endoscopy settings, such as hospitals, outpatient imaging centers, or specialized gastroenterology clinics. It is particularly useful in procedures where biliary or pancreatic imaging is necessary, such as ERCP (endoscopic retrograde cholangiopancreatography).
How is the device regulated, and what does its FDA clearance status mean for buyers?
The Da Vinci Cholangiogram Delivery Device holds an FDA 510(k) clearance (K934739), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the device meets FDA safety and effectiveness requirements for its intended use in delivering contrast media during cholangiography, providing assurance to buyers of its regulatory compliance.
What should buyers consider regarding storage and handling of this device?
Since the device is sterile and single-use, buyers should store it in a clean, dry environment away from direct sunlight or extreme temperatures. It should be kept in its original packaging until ready for use to maintain sterility. Proper inventory management is also important to ensure availability when needed for procedures.