K981233 is an FDA 510(k) clearance for the KSEA CALCUSPLIT. This device is classified as a Lithotriptor, Electro-hydraulic (Class II - Special Controls, product code FFK).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 15, 1998, 73 days after receiving the submission on April 3, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K981233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1998 |
| Decision Date | June 15, 1998 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFK — Lithotriptor, Electro-hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4480 |