K925396 is an FDA 510(k) clearance for the PULSE GUARD ELECTRODE. This device is classified as a Lithotriptor, Electro-hydraulic (Class II - Special Controls, product code FFK).
Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on July 30, 1993, 277 days after receiving the submission on October 26, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K925396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1992 |
| Decision Date | July 30, 1993 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FFK — Lithotriptor, Electro-hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4480 |