K234090 is an FDA 510(k) clearance for the EXPLORER AIR? II (8001, 8002, 8003); EXPLORER AIR? Sterile Drape (8004), a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Surgvision GmbH (Munich, DE). The FDA issued a Cleared decision on March 20, 2024, 89 days after receiving the submission on December 22, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K234090 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2023 |
| Decision Date | March 20, 2024 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1600 |