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)

OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE

K-Number: K920431 · 1992-05-29

ApplicantOmnitron Intl., Inc.
Decision Date1992-05-29
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Omnitron Intl., Inc.. It received FDA 510(k) clearance on 1992-05-29 under 510(k) number K920431. 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 OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE?

OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE is a medical device that received FDA 510(k) clearance on 1992-05-29. The listed applicant is Omnitron Intl., Inc.. The 510(k) number is K920431.

When did OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE receive FDA 510(k) clearance?

OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE received FDA 510(k) clearance on 1992-05-29, under 510(k) number K920431.

Who is the listed applicant for OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE?

The FDA 510(k) record lists Omnitron Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE?

The FDA product code for OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE 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 Omnitron Intl., Inc. 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.

K901615PULMOCATH INTRABRONCHIAL CATHETERK923130IR-192 IMPLANT -- MODIFICATIONK913908OMNITRON GYN APPLICATOR SYSTEMK915253IR-192 IMPLANT, MODIFICATIONK911775OMNICATH IMPLANTED CATHETER AND DEPOTK881665OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

View all 7 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.

↑