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FDA 510(k)

CASSIE

K-Number: K252628 · 2026-04-27

ApplicantWesper, Inc.
Decision Date2026-04-27
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CASSIE is a medical device manufactured by Wesper, Inc.. It received FDA 510(k) clearance on 2026-04-27 under approval number K252628. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASSIE?

CASSIE is a medical device that received FDA 510(k) clearance on 2026-04-27. It is manufactured by Wesper, Inc.. The 510(k) number is K252628.

When was CASSIE approved by the FDA?

CASSIE received FDA 510(k) clearance on 2026-04-27, under approval number K252628.

What company makes CASSIE?

CASSIE is manufactured by Wesper, Inc..

What is the FDA product code for CASSIE?

The FDA product code for CASSIE is MNR.

Other Devices by Wesper, Inc.

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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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