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)

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium

K-Number: K201309 · 2021-06-04

Decision Date2021-06-04
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is the device name listed in this FDA 510(k) record. The listed applicant is Mecta Corporation. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K201309. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Mecta Corporation. The 510(k) number is K201309.

When did ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium receive FDA 510(k) clearance?

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium received FDA 510(k) clearance on 2021-06-04, under 510(k) number K201309.

Who is the listed applicant for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

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

What is the FDA product code for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium?

The FDA product code for ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium is JXL.

Other records listing Mecta Corporation 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: JXL)

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.