Mendit
K-Number: K260380 · 2026-03-04
ApplicantEscala Medical, Ltd.
Decision Date2026-03-04
Product CodePBQ
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Mendit is a medical device manufactured by Escala Medical, Ltd.. It received FDA 510(k) clearance on 2026-03-04 under approval number K260380. The device is classified under product code PBQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mendit?
Mendit is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by Escala Medical, Ltd.. The 510(k) number is K260380.
When was Mendit approved by the FDA?
Mendit received FDA 510(k) clearance on 2026-03-04, under approval number K260380.
What company makes Mendit?
Mendit is manufactured by Escala Medical, Ltd..
What is the FDA product code for Mendit?
The FDA product code for Mendit is PBQ.
Related Devices (Code: PBQ)
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.