Stone Dislodger
by G.D. Searle and Co. 510(k)
Active
510(k) K800608
Overview
The Stone Dislodger is a rigid or semi-rigid wire basket device inserted through a ureteroscope or cystoscope to capture, dislodge, and retrieve stones from the ureter. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance.
The device is supplied as a metal ureteral stone basket dislodger and is regulated under product code FFL, 21 CFR 876.4680, within the Gastroenterology, Urology medical specialty. It is authorized under FDA 510K clearance with K-number K800608.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800608 | Date8 Apr 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FFL
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4680
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from G.D. Searle and Co.
Questions
What is the Stone Dislodger used for?
The Stone Dislodger is a rigid or semi-rigid wire basket device designed to be inserted through a ureteroscope or cystoscope to capture, dislodge, and retrieve stones from the ureter. It is specifically intended for urological procedures involving stone removal.
How is the Stone Dislodger supplied?
The device is supplied as a metal ureteral stone basket dislodger. It is a single-use device and should not be reused on different patients due to infection control and sterility concerns.
What is the regulatory status of the Stone Dislodger?
The Stone Dislodger is classified as FDA Class 2, indicating moderate risk, and has received 510(k) premarket clearance with K-number K800608. It is regulated under product code FFL, 21 CFR 876.4680, within the Gastroenterology, Urology medical specialty.
What sizes and models of the Stone Dislodger are available?
The device data does not specify available sizes or models. The Stone Dislodger is described as a rigid or semi-rigid wire basket device, but specific dimensions or variations are not provided in the regulatory information.
How should the Stone Dislodger be stored?
The device data does not include specific storage instructions. As a medical device, it should typically be stored in a clean, dry environment as recommended by the manufacturer, away from extreme temperatures or conditions that could compromise its integrity.