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FDA 510(k)

ENTERIC INJECTION CATHETER WITH IRRIGATION

K-Number: K002778 · 2000-11-22

ApplicantEnteric Medical Technologies, Inc.
Decision Date2000-11-22
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTERIC INJECTION CATHETER WITH IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Enteric Medical Technologies, Inc.. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K002778. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERIC INJECTION CATHETER WITH IRRIGATION?

ENTERIC INJECTION CATHETER WITH IRRIGATION is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Enteric Medical Technologies, Inc.. The 510(k) number is K002778.

When did ENTERIC INJECTION CATHETER WITH IRRIGATION receive FDA 510(k) clearance?

ENTERIC INJECTION CATHETER WITH IRRIGATION received FDA 510(k) clearance on 2000-11-22, under 510(k) number K002778.

Who is the listed applicant for ENTERIC INJECTION CATHETER WITH IRRIGATION?

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

What is the FDA product code for ENTERIC INJECTION CATHETER WITH IRRIGATION?

The FDA product code for ENTERIC INJECTION CATHETER WITH IRRIGATION is FBK.

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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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