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FDA 510(k)

IMPLANT GUIDANCE SYSTEM APPLICATOR SET

K-Number: K020015 · 2002-03-13

ApplicantNucletron Corp.
Decision Date2002-03-13
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPLANT GUIDANCE SYSTEM APPLICATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2002-03-13 under 510(k) number K020015. 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 IMPLANT GUIDANCE SYSTEM APPLICATOR SET?

IMPLANT GUIDANCE SYSTEM APPLICATOR SET is a medical device that received FDA 510(k) clearance on 2002-03-13. The listed applicant is Nucletron Corp.. The 510(k) number is K020015.

When did IMPLANT GUIDANCE SYSTEM APPLICATOR SET receive FDA 510(k) clearance?

IMPLANT GUIDANCE SYSTEM APPLICATOR SET received FDA 510(k) clearance on 2002-03-13, under 510(k) number K020015.

Who is the listed applicant for IMPLANT GUIDANCE SYSTEM APPLICATOR SET?

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 IMPLANT GUIDANCE SYSTEM APPLICATOR SET?

The FDA product code for IMPLANT GUIDANCE SYSTEM APPLICATOR SET 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 - DIGITALK041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001K041933MICROSELECTRON PDRK041719ONCENTRA-VISIR

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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.

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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