Coaxial Electrode #300A
by K-Med, Inc. 510(k)
Active
510(k) K832566
Overview
The Coaxial Electrode #300A is an electro-hydraulic lithotriptor. This device is designed for use in gastroenterology and urology procedures.
This device is identified by FDA 510(k) clearance number K832566. It is classified under regulation number 876.4480 and product code FFK.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832566 | Date28 Nov 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 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
Other devices from K-Med, Inc.
Questions
What is the primary clinical use of the Coaxial Electrode #300A?
The Coaxial Electrode #300A is an electro-hydraulic lithotriptor intended for use in gastroenterology and urology procedures to assist in the fragmentation of calculi.
Is this device cleared for use by the FDA?
Yes, the Coaxial Electrode #300A has received FDA 510(k) clearance, identified by clearance number K832566. This indicates the device has been found substantially equivalent to legally marketed predicate devices.
Under which regulatory classification does this lithotriptor fall?
This device is classified under regulation number 876.4480, which pertains to electro-hydraulic lithotriptors, and is assigned product code FFK within the gastroenterology and urology medical specialties.