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FDA 510(k)

MEDISYSTEMS FISTULA NEEDLES

K-Number: K823068 · 1983-01-26

ApplicantMedisystems Corp.
Decision Date1983-01-26
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDISYSTEMS FISTULA NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K823068. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISYSTEMS FISTULA NEEDLES?

MEDISYSTEMS FISTULA NEEDLES is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Medisystems Corp.. The 510(k) number is K823068.

When did MEDISYSTEMS FISTULA NEEDLES receive FDA 510(k) clearance?

MEDISYSTEMS FISTULA NEEDLES received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823068.

Who is the listed applicant for MEDISYSTEMS FISTULA NEEDLES?

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

What is the FDA product code for MEDISYSTEMS FISTULA NEEDLES?

The FDA product code for MEDISYSTEMS FISTULA NEEDLES is KOC.

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Other records listing Medisystems 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.

K062953MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICEK010279MEDISYSTEMS LUER ACCESS INJECTION SITEK002372ACCESS ALERT GAUGEK994306REVERSOK990803MEDISYSTEMS BUTTONHOLE NEEDLE SETSK983076MEDISYSTEMS TRANSDUCER PROTECTOR

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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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