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FDA 510(k)

sOLVe Tube

K-Number: K201026 · 2021-08-10

ApplicantHytek Medical, Inc.
Decision Date2021-08-10
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

sOLVe Tube is a medical device manufactured by Hytek Medical, Inc.. It received FDA 510(k) clearance on 2021-08-10 under approval number K201026. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the sOLVe Tube?

sOLVe Tube is a medical device that received FDA 510(k) clearance on 2021-08-10. It is manufactured by Hytek Medical, Inc.. The 510(k) number is K201026.

When was sOLVe Tube approved by the FDA?

sOLVe Tube received FDA 510(k) clearance on 2021-08-10, under approval number K201026.

What company makes sOLVe Tube?

sOLVe Tube is manufactured by Hytek Medical, Inc..

What is the FDA product code for sOLVe Tube?

The FDA product code for sOLVe Tube is CBI.

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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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