Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

ApplicantMecta Corporation
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 a medical device manufactured by Mecta Corporation. It received FDA 510(k) clearance on 2021-06-04 under approval 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. It is manufactured by Mecta Corporation. The 510(k) number is K201309.

When was ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium approved by the FDA?

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

What company makes 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 manufactured by Mecta Corporation.

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.

Related Clinical Trials

NCT07604142 Allogenic Bone Block for Oro-Antral Communication Closure for Subsequent Implant Placement ENROLLING_BY_INVITATION NCT06364865 AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study COMPLETED NCT07514351 FANS vs CVAC for Medium to Large Stones NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41302949 Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. Journal of clinical medicine (2025)

Other Devices by Mecta Corporation

K192834MECTA Sigma

Related Devices (Code: JXL)

K172978SurgeoBiteSurgovations, LLC K221469PATI (Protector Against Tongue Injury)Neurovice, LLC

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.

↑