Olympus NBD Tubes
510(k) K944912
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944912 | Date13 Jun 1995 | 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- Withdrawn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
- FGE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5010
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Olympus NBD Tubes are classified as Stents, Drains, and Dilators for the Biliary Ducts, a category of medical devices designed to facilitate biliary drainage or dilation. These tubes are intended for use in procedures involving the biliary system, such as relieving obstructions or managing bile flow in patients with conditions like cholangitis or biliary strictures. Constructed to ensure compatibility with the biliary anatomy, they provide mechanical support or patency to affected ducts.
Olympus NBD Tubes are supplied as single-use, sterile devices and are regulated under FDA 510(k) clearance (K944912) with a classification of Class II (FGE product code). They are intended for use in clinical settings such as endoscopy or interventional radiology, where biliary interventions are performed. The devices are packaged for sterile use and must be stored according to manufacturer guidelines to maintain integrity until deployment. No MRI safety information is specified, and sizes or additional technical specifications are not detailed in the provided data.
Other devices from Olympus America, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are Olympus NBD Tubes used for?
Olympus NBD Tubes are designed for biliary drainage or dilation procedures. They provide mechanical support or maintain patency in the biliary ducts, helping to relieve obstructions or manage bile flow in patients with conditions like cholangitis or biliary strictures. These tubes are specifically engineered to fit the biliary anatomy, ensuring compatibility during interventions such as endoscopy or interventional radiology.
Are Olympus NBD Tubes single-use or reusable?
Olympus NBD Tubes are intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients, adhering to best practices for medical device safety and regulatory compliance.
How should Olympus NBD Tubes be stored?
Olympus NBD Tubes must be stored according to the manufacturer’s guidelines to maintain their sterility and integrity until deployment. Proper storage conditions typically include a clean, dry environment, away from direct sunlight or extreme temperatures, and within the expiration date specified on the packaging.
What regulatory clearance do Olympus NBD Tubes hold?
Olympus NBD Tubes are cleared under the FDA’s 510(k) pathway with the clearance number K944912. They fall under the classification of Class II devices, specifically categorized under the product code FGE (Stents, Drains, and Dilators for the Biliary Ducts). This clearance confirms their substantial equivalence to a predicate device.
Are there specific sizes or technical specifications for Olympus NBD Tubes?
The provided data does not specify exact sizes or detailed technical specifications for Olympus NBD Tubes. For precise sizing or technical details, refer to the manufacturer’s product documentation or contact Olympus America, Inc. directly.