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FDA 510(k)

IR-192 IMPLANT, MODIFICATION

K-Number: K915253 · 1992-02-27

ApplicantOmnitron Intl., Inc.
Decision Date1992-02-27
Product CodeIWA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IR-192 IMPLANT, MODIFICATION 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 1992-02-27 under 510(k) number K915253. The device is classified under product code IWA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IR-192 IMPLANT, MODIFICATION?

IR-192 IMPLANT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Omnitron Intl., Inc.. The 510(k) number is K915253.

When did IR-192 IMPLANT, MODIFICATION receive FDA 510(k) clearance?

IR-192 IMPLANT, MODIFICATION received FDA 510(k) clearance on 1992-02-27, under 510(k) number K915253.

Who is the listed applicant for IR-192 IMPLANT, MODIFICATION?

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 IR-192 IMPLANT, MODIFICATION?

The FDA product code for IR-192 IMPLANT, MODIFICATION is IWA.

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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 -- MODIFICATIONK920431OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGEK913908OMNITRON GYN APPLICATOR SYSTEMK911775OMNICATH IMPLANTED CATHETER AND DEPOTK881665OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

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Related Devices (Code: IWA)

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.

K894409CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDAmersham Corp.K874895IR-192 IMPLANTRads S.L., Inc.K850382IRIDIUM SEEDSRadiation Safety & Nuclear Products, Inc.K844248IR-192 IMPLANTRads S.L., Inc.K850163IRIDIUM 192 WIRESSyncor Intl. Corp.K850726WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELDSyncor Intl. Corp.

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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