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FDA 510(k)

UMI CURVED CHEMONUCLEOLYSIS NEEDLE

K-Number: K842012 · 1984-07-06

Decision Date1984-07-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UMI CURVED CHEMONUCLEOLYSIS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1984-07-06 under 510(k) number K842012. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UMI CURVED CHEMONUCLEOLYSIS NEEDLE?

UMI CURVED CHEMONUCLEOLYSIS NEEDLE is a medical device that received FDA 510(k) clearance on 1984-07-06. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K842012.

When did UMI CURVED CHEMONUCLEOLYSIS NEEDLE receive FDA 510(k) clearance?

UMI CURVED CHEMONUCLEOLYSIS NEEDLE received FDA 510(k) clearance on 1984-07-06, under 510(k) number K842012.

Who is the listed applicant for UMI CURVED CHEMONUCLEOLYSIS NEEDLE?

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

What is the FDA product code for UMI CURVED CHEMONUCLEOLYSIS NEEDLE?

The FDA product code for UMI CURVED CHEMONUCLEOLYSIS NEEDLE is FMI.

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.

Other records listing Universal Medical Instrument 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.

View all 21 devices →

Related Devices (Code: FMI)

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.

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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