SpyScope Access and Delivery Catheter
by Boston Scientific 2 variants
510(k) K051504
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051504 | Date16 Jun 2005 | StatusActive |
Official records
- FDA 510(k) database K051504
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FED
- FDA applicant
- Boston Scientific Corp
- 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 SpyScope Access and Delivery Catheter is classified as an Endoscopic Access Overtube, designed for use in gastroenterology and urology procedures. It facilitates direct visualization of bile ducts, pancreatic ducts, and other internal structures, enabling diagnostic and therapeutic interventions such as stone removal, stricture management, and tissue inspection.
This catheter is supplied as a single-use, non-sterile device and is intended for use with compatible diagnostic and therapeutic accessories. It is compatible with MRI environments and is available in various sizes as specified in the regulatory submissions. The device holds FDA 510K clearance under the classification of Class II medical devices, adhering to regulatory standards for endoscopic access tools.