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)

PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067

K-Number: K003270 · 2000-12-22

ApplicantNucletron Corp.
Decision Date2000-12-22
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 2000-12-22 under 510(k) number K003270. 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 PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067?

PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 is a medical device that received FDA 510(k) clearance on 2000-12-22. The listed applicant is Nucletron Corp.. The 510(k) number is K003270.

When did PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 receive FDA 510(k) clearance?

PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 received FDA 510(k) clearance on 2000-12-22, under 510(k) number K003270.

Who is the listed applicant for PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067?

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 PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067?

The FDA product code for PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 is JAQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 27 devices →

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.

↑