EVOCLEAN CLEANsert Ultrasonic Insert
K-Number: K210832 · 2022-02-02
ApplicantTtbio Corp.
Decision Date2022-02-02
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EVOCLEAN CLEANsert Ultrasonic Insert is a medical device manufactured by Ttbio Corp.. It received FDA 510(k) clearance on 2022-02-02 under approval number K210832. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EVOCLEAN CLEANsert Ultrasonic Insert?
EVOCLEAN CLEANsert Ultrasonic Insert is a medical device that received FDA 510(k) clearance on 2022-02-02. It is manufactured by Ttbio Corp.. The 510(k) number is K210832.
When was EVOCLEAN CLEANsert Ultrasonic Insert approved by the FDA?
EVOCLEAN CLEANsert Ultrasonic Insert received FDA 510(k) clearance on 2022-02-02, under approval number K210832.
What company makes EVOCLEAN CLEANsert Ultrasonic Insert?
EVOCLEAN CLEANsert Ultrasonic Insert is manufactured by Ttbio Corp..
What is the FDA product code for EVOCLEAN CLEANsert Ultrasonic Insert?
The FDA product code for EVOCLEAN CLEANsert Ultrasonic Insert is ELC.
Other Devices by Ttbio Corp.
Related Devices (Code: ELC)
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.