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FDA 510(k)

Zsquare ENT-Flex Endoscope

K-Number: K220004 · 2022-06-14

ApplicantZsquare, Ltd.
Decision Date2022-06-14
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Zsquare ENT-Flex Endoscope is the device name listed in this FDA 510(k) record. The listed applicant is Zsquare, Ltd.. It received FDA 510(k) clearance on 2022-06-14 under 510(k) number K220004. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zsquare ENT-Flex Endoscope?

Zsquare ENT-Flex Endoscope is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is Zsquare, Ltd.. The 510(k) number is K220004.

When did Zsquare ENT-Flex Endoscope receive FDA 510(k) clearance?

Zsquare ENT-Flex Endoscope received FDA 510(k) clearance on 2022-06-14, under 510(k) number K220004.

Who is the listed applicant for Zsquare ENT-Flex Endoscope?

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

What is the FDA product code for Zsquare ENT-Flex Endoscope?

The FDA product code for Zsquare ENT-Flex Endoscope is EOB.

Related Devices (Code: EOB)

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.

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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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