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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 a medical device manufactured by Nucletron B.V.. It received FDA 510(k) clearance on 2017-01-27 under approval 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. It is manufactured by Nucletron B.V.. The 510(k) number is K161688.

When was Advanced Gynecological Applicator approved by the FDA?

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

What company makes Advanced Gynecological Applicator?

Advanced Gynecological Applicator is manufactured by Nucletron B.V..

What is the FDA product code for Advanced Gynecological Applicator?

The FDA product code for Advanced Gynecological Applicator is JAQ.

Related Clinical Trials

NCT07394777 An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis COMPLETED

Other Devices by Nucletron B.V.

K201272Geneva K213942Esteya K251037Rectal Applicator

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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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