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)

AdTec

K-Number: K160393 · 2016-05-26

Decision Date2016-05-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AdTec is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K160393. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AdTec?

AdTec is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Aesculap, Inc.. The 510(k) number is K160393.

When did AdTec receive FDA 510(k) clearance?

AdTec received FDA 510(k) clearance on 2016-05-26, under 510(k) number K160393.

Who is the listed applicant for AdTec?

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

What is the FDA product code for AdTec?

The FDA product code for AdTec is GCJ.

Related Clinical Trials

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.

Other records listing Aesculap, Inc. 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.

View all 34 devices →

Related Devices (Code: GCJ)

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.