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FDA 510(k)

INCL ENDOSCOPE

K-Number: K955471 · 1995-12-18

ApplicantSofamor Danek USA,Inc.
Decision Date1995-12-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

INCL ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K955471. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INCL ENDOSCOPE?

INCL ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K955471.

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

INCL ENDOSCOPE received FDA 510(k) clearance on 1995-12-18, under 510(k) number K955471.

Who is the listed applicant for INCL ENDOSCOPE?

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

What is the FDA product code for INCL ENDOSCOPE?

The FDA product code for INCL 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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