K232406 is an FDA 510(k) clearance for the KARL STORZ OR1™ SCB CONTROL (WU300). This device is classified as a Endoscopic Central Control Unit (Class II - Special Controls, product code ODA).
Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on October 3, 2023, 54 days after receiving the submission on August 10, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command..
| 510(k) Number | K232406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2023 |
| Decision Date | October 03, 2023 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ODA — Endoscopic Central Control Unit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command. |