K944571 is an FDA 510(k) clearance for the PULSE GUARD 3FR ELECTRODE, 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 March 17, 1995, 179 days after receiving the submission on September 19, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K944571 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 1994 |
| Decision Date | March 17, 1995 |
| Days to Decision | 179 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 |