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FDA 510(k)

WINGED FISTULA NEEDLE

K-Number: K760935 · 1976-11-19

ApplicantGambro, Inc.
Decision Date1976-11-19
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WINGED FISTULA NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1976-11-19 under 510(k) number K760935. 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 WINGED FISTULA NEEDLE?

WINGED FISTULA NEEDLE is a medical device that received FDA 510(k) clearance on 1976-11-19. The listed applicant is Gambro, Inc.. The 510(k) number is K760935.

When did WINGED FISTULA NEEDLE receive FDA 510(k) clearance?

WINGED FISTULA NEEDLE received FDA 510(k) clearance on 1976-11-19, under 510(k) number K760935.

Who is the listed applicant for WINGED FISTULA NEEDLE?

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

What is the FDA product code for WINGED FISTULA NEEDLE?

The FDA product code for WINGED FISTULA NEEDLE is KOC.

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Other records listing Gambro, Inc. as applicant

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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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