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FDA 510(k)

KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)

K-Number: K000046 · 2000-03-30

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date2000-03-30
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2000-03-30 under 510(k) number K000046. 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 KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)?

KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) is a medical device that received FDA 510(k) clearance on 2000-03-30. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K000046.

When did KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) receive FDA 510(k) clearance?

KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) received FDA 510(k) clearance on 2000-03-30, under 510(k) number K000046.

Who is the listed applicant for KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)?

The FDA product code for KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) 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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