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FDA 510(k)

3NT endoscopy system

K-Number: K162916 · 2017-02-24

Decision Date2017-02-24
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

3NT 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 2017-02-24 under 510(k) number K162916. 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 3NT endoscopy system?

3NT endoscopy system is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is 3nt Medical , Ltd.. The 510(k) number is K162916.

When did 3NT endoscopy system receive FDA 510(k) clearance?

3NT endoscopy system received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162916.

Who is the listed applicant for 3NT 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 3NT endoscopy system?

The FDA product code for 3NT 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.

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.

Official Source

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