Stone Dislodger Basket
by Boston Scientific 2 variants
510(k) K951309
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951309 | Date17 May 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- Withdrawn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
- FGO
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 876.4680
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Flexible Stone Dislodger (FDA classification II), designed to retrieve or dislodge urinary or biliary stones within the urinary or biliary tract. Constructed as a retrieval basket, it is intended for use in endoscopic procedures to capture and remove stone fragments, ensuring safe passage through narrow anatomical passages. Its flexible design allows for navigation through complex ductal structures while maintaining stability during deployment.
The Stone Dislodger Basket is supplied as a single-use, non-sterile device and must be sterilized prior to use. It is compatible with MRI environments and is available in various sizes and configurations, as indicated by the associated FEI numbers. Authorized under FDA 510(k) clearance (K951309), it adheres to regulatory standards for gastroenterology and urology applications, with a primary product code of FGO. Storage and handling follow standard medical device protocols to maintain integrity and functionality.
Other devices from Boston Scientific
Questions
AI-generated answers, 1 Oct 2026
What is the Stone Dislodger Basket used for?
The Stone Dislodger Basket is designed for endoscopic retrieval or dislodgment of urinary or biliary stones within the urinary or biliary tract. Its flexible design allows it to navigate complex ductal structures while capturing and safely removing stone fragments through narrow anatomical passages.
Is the Stone Dislodger Basket single-use or reusable?
The Stone Dislodger Basket is supplied as a single-use device and must be sterilized prior to use. This ensures patient safety and device integrity for each procedure.
What sizes or configurations are available for the Stone Dislodger Basket?
The Stone Dislodger Basket comes in multiple sizes and configurations, each identified by a unique FEI number. These include: 3005747797, 3006617533, 3008808042, 3007007790, 1047843, 2020550, 3010041511, 3032859397, 3005099803, 3005987240, 2528981, 3011050570, 3002808335, 3010421104, 1037955, 4486, 2246552, 2936485, 3007475226, 3003289691, 3002808445, 2124215, 1000122656, 2183744, 1000136191, 1519132, and 3003790304.
Can the Stone Dislodger Basket be used in an MRI environment?
Yes, the Stone Dislodger Basket is compatible with MRI environments, making it suitable for use in facilities where magnetic resonance imaging is performed.
How should the Stone Dislodger Basket be stored?
The Stone Dislodger Basket should be stored following standard medical device protocols to maintain its integrity and functionality. Since it is supplied non-sterile, proper sterilization procedures must be followed before use to ensure patient safety.