K010785 is an FDA 510(k) clearance for the KSEA DION-GRACIA SET. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 21, 2001, 159 days after receiving the submission on March 15, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K010785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2001 |
| Decision Date | August 21, 2001 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |