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FDA 510(k)

CapsoView (CVV); CapsoCloud (CLD)

K-Number: K254230 · 2026-09-25

ApplicantCapsoVision, Inc.
Decision Date2026-09-25
Product CodeQZF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CapsoView (CVV); CapsoCloud (CLD) is the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254230. The device is classified under product code QZF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CapsoView (CVV); CapsoCloud (CLD)?

CapsoView (CVV); CapsoCloud (CLD) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is CapsoVision, Inc.. The 510(k) number is K254230.

When did CapsoView (CVV); CapsoCloud (CLD) receive FDA 510(k) clearance?

CapsoView (CVV); CapsoCloud (CLD) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254230.

Who is the listed applicant for CapsoView (CVV); CapsoCloud (CLD)?

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

What is the FDA product code for CapsoView (CVV); CapsoCloud (CLD)?

The FDA product code for CapsoView (CVV); CapsoCloud (CLD) is QZF.

Other records listing CapsoVision, Inc. as applicant

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Related Devices (Code: QZF)

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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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