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FDA 510(k)

INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001

K-Number: K041715 · 2005-03-24

ApplicantNucletron Corp.
Decision Date2005-03-24
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K041715. 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 INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001?

INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Nucletron Corp.. The 510(k) number is K041715.

When did INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 receive FDA 510(k) clearance?

INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 received FDA 510(k) clearance on 2005-03-24, under 510(k) number K041715.

Who is the listed applicant for INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001?

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

What is the FDA product code for INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001?

The FDA product code for INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 is JAQ.

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Other records listing Nucletron Corp. 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.

K092804MICROSELECTRON HDR V2, MODEL 105.999K091598LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERSK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALK041933MICROSELECTRON PDRK041719ONCENTRA-VISIRK031349OTP 1.2

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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.

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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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