Riwolith 2280
by Richard Wolf Medical Instruments Corp. 510(k)
Active
510(k) K913487
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913487 | Date5 Feb 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FFK
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4480
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Riwolith 2280 is an electro-hydraulic lithotriptor, a device designed to fragment urinary stones using high-energy shock waves generated by electrical discharge. It operates by converting electrical energy into hydraulic pressure within a fluid medium, creating shock waves that shatter calculi in the urinary tract. This procedure is commonly used in urology and gastroenterology to treat kidney, ureteral, or bladder stones without invasive surgery.
The Riwolith 2280 is supplied as a reusable medical device and is classified under FDA product code FFK, falling under Class II with special controls. It is intended for use in clinical settings such as operating rooms or endoscopy suites, where it is connected to a power source and fluid delivery system. The device requires proper maintenance, sterilization, and storage as per manufacturer guidelines to ensure safety and functionality. Its regulatory status includes FDA 510(k) clearance under K913487, authorized for use in gastroenterology and urology procedures.
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