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FDA 510(k)

ENDO A CLASS

K-Number: K123582 · 2013-08-16

ApplicantSaeyang Microtech Co., Ltd.
Decision Date2013-08-16
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO A CLASS is the device name listed in this FDA 510(k) record. The listed applicant is Saeyang Microtech Co., Ltd.. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K123582. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO A CLASS?

ENDO A CLASS is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Saeyang Microtech Co., Ltd.. The 510(k) number is K123582.

When did ENDO A CLASS receive FDA 510(k) clearance?

ENDO A CLASS received FDA 510(k) clearance on 2013-08-16, under 510(k) number K123582.

Who is the listed applicant for ENDO A CLASS?

The FDA 510(k) record lists Saeyang Microtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO A CLASS?

The FDA product code for ENDO A CLASS is EKX.

Related Clinical Trials

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Other records listing Saeyang Microtech Co., 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.

K213897Pro M ClassK123608ENDO E CLASS

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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.

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