FDA 510(k)

FISTULA NEEDLE (#11-265)

K-Number: K760665 · 1976-10-21

Decision Date1976-10-21

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FISTULA NEEDLE (#11-265) is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1976-10-21 under 510(k) number K760665. 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 FISTULA NEEDLE (#11-265)?

FISTULA NEEDLE (#11-265) is a medical device that received FDA 510(k) clearance on 1976-10-21. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K760665.

When did FISTULA NEEDLE (#11-265) receive FDA 510(k) clearance?

FISTULA NEEDLE (#11-265) received FDA 510(k) clearance on 1976-10-21, under 510(k) number K760665.

Who is the listed applicant for FISTULA NEEDLE (#11-265)?

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

What is the FDA product code for FISTULA NEEDLE (#11-265)?

The FDA product code for FISTULA NEEDLE (#11-265) is KOC.

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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.