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FDA 510(k)

Esteya

K-Number: K213942 · 2022-01-11

ApplicantNucletron B.V.
Decision Date2022-01-11
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Esteya is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213942. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esteya?

Esteya is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Nucletron B.V.. The 510(k) number is K213942.

When did Esteya receive FDA 510(k) clearance?

Esteya received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213942.

Who is the listed applicant for Esteya?

The FDA 510(k) record lists Nucletron B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esteya?

The FDA product code for Esteya is JAD.

Other records listing Nucletron B.V. 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.

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Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.K173425SRT-100+Sensus Healthcare, 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.

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