K973251 is an FDA 510(k) clearance for the KSEA CALCUSON. This device is classified as a Lithotriptor, Ultrasonic (Class II - Special Controls, product code FEO).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 22, 1998, 297 days after receiving the submission on August 29, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K973251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1997 |
| Decision Date | June 22, 1998 |
| Days to Decision | 297 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEO — Lithotriptor, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4480 |