FDA 510(k)

Capsulo

K-Number: K220430 · 2022-05-12

Decision Date2022-05-12

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Capsulo is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K220430. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capsulo?

Capsulo is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Quantel Medical. The 510(k) number is K220430.

When did Capsulo receive FDA 510(k) clearance?

Capsulo received FDA 510(k) clearance on 2022-05-12, under 510(k) number K220430.

Who is the listed applicant for Capsulo?

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

What is the FDA product code for Capsulo?

The FDA product code for Capsulo is HQF.

Other records listing Quantel Medical as applicant

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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.