Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ttbio Corp.. It received FDA 510(k) clearance on 2022-02-02 under 510(k) 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. The listed applicant is Ttbio Corp.. The 510(k) number is K210832.

When did EVOCLEAN CLEANsert Ultrasonic Insert receive FDA 510(k) clearance?

EVOCLEAN CLEANsert Ultrasonic Insert received FDA 510(k) clearance on 2022-02-02, under 510(k) number K210832.

Who is the listed applicant for EVOCLEAN CLEANsert Ultrasonic Insert?

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

What is the FDA product code for EVOCLEAN CLEANsert Ultrasonic Insert?

The FDA product code for EVOCLEAN CLEANsert Ultrasonic Insert is ELC.

Other records listing Ttbio Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ELC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.