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FDA 510(k)

EXPLORER AIR® II

K-Number: K222240 · 2023-02-28

ApplicantSurgvision GmbH
Decision Date2023-02-28
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPLORER AIR® II is the device name listed in this FDA 510(k) record. The listed applicant is Surgvision GmbH. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K222240. 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 2023-02-28. The listed applicant is Surgvision GmbH. The 510(k) number is K222240.

When did EXPLORER AIR® II receive FDA 510(k) clearance?

EXPLORER AIR® II received FDA 510(k) clearance on 2023-02-28, under 510(k) number K222240.

Who is the listed applicant for EXPLORER AIR® II?

The FDA 510(k) record lists Surgvision GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPLORER AIR® II?

The FDA product code for EXPLORER AIR® II is IZI.

Other records listing Surgvision GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)K214097Explorer Air II

Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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.

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