Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Explorer Air II

K-Number: K214097 · 2022-02-25

ApplicantSurgvision GmbH
Decision Date2022-02-25
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Explorer Air II is a medical device manufactured by Surgvision GmbH. It received FDA 510(k) clearance on 2022-02-25 under approval number K214097. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Explorer Air II?

Explorer Air II is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Surgvision GmbH. The 510(k) number is K214097.

When was Explorer Air II approved by the FDA?

Explorer Air II received FDA 510(k) clearance on 2022-02-25, under approval number K214097.

What company makes Explorer Air II?

Explorer Air II is manufactured by Surgvision GmbH.

What is the FDA product code for Explorer Air II?

The FDA product code for Explorer Air II is IZI.

Other Devices by Surgvision GmbH

K222240EXPLORER AIR® II K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

Related Devices (Code: IZI)

K151780CAAS WorkstationPie Medical Imaging BV K162991YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec, AG K170239Leica FL560Leica Microsystems (Schweiz) AG K181537GLOW800Leica Microsystems (Schweiz) AG K180019CAAS WorkstationPie Medical Imaging BV K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑