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FDA 510(k)

INCL II ENDOSCOPE

K-Number: K963642 · 1998-03-18

ApplicantSofamor Danek USA,Inc.
Decision Date1998-03-18
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INCL II 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 1998-03-18 under 510(k) number K963642. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCL II ENDOSCOPE?

INCL II ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1998-03-18. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K963642.

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

INCL II ENDOSCOPE received FDA 510(k) clearance on 1998-03-18, under 510(k) number K963642.

Who is the listed applicant for INCL II 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 II ENDOSCOPE?

The FDA product code for INCL II ENDOSCOPE is GWG.

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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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