Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rectal Applicator

K-Number: K251037 · 2025-12-19

ApplicantNucletron B.V.
Decision Date2025-12-19
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rectal 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 2025-12-19 under 510(k) 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. The listed applicant is Nucletron B.V.. The 510(k) number is K251037.

When did Rectal Applicator receive FDA 510(k) clearance?

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

Who is the listed applicant for Rectal 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 Rectal Applicator?

The FDA product code for Rectal 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 AzureK213942EsteyaK201272GenevaK161688Advanced Gynecological Applicator

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 SystemsK252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical SystemsK243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)Varian Medical Systems, 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.

↑