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)

Colibri Endoscopy System

K-Number: K192305 · 2020-02-27

Applicant3nt Medical , Ltd.
Decision Date2020-02-27
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Colibri Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is 3nt Medical , Ltd.. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K192305. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colibri Endoscopy System?

Colibri Endoscopy System is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is 3nt Medical , Ltd.. The 510(k) number is K192305.

When did Colibri Endoscopy System receive FDA 510(k) clearance?

Colibri Endoscopy System received FDA 510(k) clearance on 2020-02-27, under 510(k) number K192305.

Who is the listed applicant for Colibri Endoscopy System?

The FDA 510(k) record lists 3nt Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Colibri Endoscopy System?

The FDA product code for Colibri Endoscopy System is EOB.

Other records listing 3nt Medical , Ltd. 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.

K202727Peregrine Endoscopy SystemK181838Sinusway Dilation SystemK1629163NT endoscopy system

Related Devices (Code: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.

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.

↑