Explorer Air II
FDA 510(k) K214097 · Surgvision GmbH
510(k) numberK214097
Submission
- Device name
- Explorer Air II
- Applicant
- Surgvision GmbH
Munich, DE - Received
- December 28, 2021
- Decision date
- February 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional | Carl Zeiss Meditec, Inc. | 06/20/2023SE |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Novadaq Technologies Ulc (A Part of Stryker) | 06/05/2023SE |
| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
| K202391 | Dir 800IZI · Traditional | Aesculap, Inc. | 01/21/2021SE |
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Questions and answers
When was Explorer Air II cleared by the FDA?
Explorer Air II (K214097) received a 510(k) decision of Substantially Equivalent on February 25, 2022, 59 days after the submission was received.
What is the product code of K214097?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.