FDA 510(k)

Rectal Applicator

K-Number: K251037 · 2025-12-19

Decision Date2025-12-19

Product CodeJAQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rectal Applicator is a medical device manufactured by Nucletron B.V.. It received FDA 510(k) clearance on 2025-12-19 under approval number K251037. 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 Rectal Applicator?

Rectal Applicator is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Nucletron B.V.. The 510(k) number is K251037.

When was Rectal Applicator approved by the FDA?

Rectal Applicator received FDA 510(k) clearance on 2025-12-19, under approval number K251037.

What company makes Rectal Applicator?

Rectal Applicator is manufactured by Nucletron B.V..

What is the FDA product code for Rectal Applicator?

The FDA product code for Rectal Applicator is JAQ.

Other Devices by Nucletron B.V.

K161688Advanced Gynecological Applicator K201272Geneva K213942Esteya

Related Devices (Code: JAQ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.