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FDA 510(k)

INTRA-SONIX UROFIBER

K-Number: K943117 · 1994-08-04

ApplicantIntra-Sonix, Inc.
Decision Date1994-08-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTRA-SONIX UROFIBER is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Sonix, Inc.. It received FDA 510(k) clearance on 1994-08-04 under 510(k) number K943117. 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 INTRA-SONIX UROFIBER?

INTRA-SONIX UROFIBER is a medical device that received FDA 510(k) clearance on 1994-08-04. The listed applicant is Intra-Sonix, Inc.. The 510(k) number is K943117.

When did INTRA-SONIX UROFIBER receive FDA 510(k) clearance?

INTRA-SONIX UROFIBER received FDA 510(k) clearance on 1994-08-04, under 510(k) number K943117.

Who is the listed applicant for INTRA-SONIX UROFIBER?

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

What is the FDA product code for INTRA-SONIX UROFIBER?

The FDA product code for INTRA-SONIX UROFIBER 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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