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FDA 510(k)

INCLUSIVE ENDOSCOPE

K-Number: K943356 · 1995-05-10

ApplicantDanek Medical, Inc.
Decision Date1995-05-10
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INCLUSIVE ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K943356. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCLUSIVE ENDOSCOPE?

INCLUSIVE ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Danek Medical, Inc.. The 510(k) number is K943356.

When did INCLUSIVE ENDOSCOPE receive FDA 510(k) clearance?

INCLUSIVE ENDOSCOPE received FDA 510(k) clearance on 1995-05-10, under 510(k) number K943356.

Who is the listed applicant for INCLUSIVE ENDOSCOPE?

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

What is the FDA product code for INCLUSIVE ENDOSCOPE?

The FDA product code for INCLUSIVE ENDOSCOPE is HRX.

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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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