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FDA 510(k)

Advanced Gynecological Applicator

K-Number: K161688 · 2017-01-27

ApplicantNucletron B.V.
Decision Date2017-01-27
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advanced Gynecological Applicator 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 2017-01-27 under 510(k) number K161688. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanced Gynecological Applicator?

Advanced Gynecological Applicator is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Nucletron B.V.. The 510(k) number is K161688.

When did Advanced Gynecological Applicator receive FDA 510(k) clearance?

Advanced Gynecological Applicator received FDA 510(k) clearance on 2017-01-27, under 510(k) number K161688.

Who is the listed applicant for Advanced Gynecological Applicator?

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 Advanced Gynecological Applicator?

The FDA product code for Advanced Gynecological Applicator is JAQ.

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.

K262383LumenCare AzureK251037Rectal ApplicatorK213942EsteyaK201272Geneva

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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