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FDA 510(k)

IOTEC TROCAR AND FLEXIBLE CANNULA

K-Number: K970888 · 1998-01-09

ApplicantIotec Industries
Decision Date1998-01-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IOTEC TROCAR AND FLEXIBLE CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Iotec Industries. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K970888. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOTEC TROCAR AND FLEXIBLE CANNULA?

IOTEC TROCAR AND FLEXIBLE CANNULA is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Iotec Industries. The 510(k) number is K970888.

When did IOTEC TROCAR AND FLEXIBLE CANNULA receive FDA 510(k) clearance?

IOTEC TROCAR AND FLEXIBLE CANNULA received FDA 510(k) clearance on 1998-01-09, under 510(k) number K970888.

Who is the listed applicant for IOTEC TROCAR AND FLEXIBLE CANNULA?

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

What is the FDA product code for IOTEC TROCAR AND FLEXIBLE CANNULA?

The FDA product code for IOTEC TROCAR AND FLEXIBLE CANNULA is GCJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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