K232406 is an FDA 510(k) clearance for the KARL STORZ OR1? SCB CONTROL (WU300), 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 review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K232406 FDA.gov |
| FDA Decision | Cleared 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. |