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FDA 510(k)

DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY

K-Number: K930191 · 1995-09-26

ApplicantSofamor Danek Mfg., Inc.
Decision Date1995-09-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1995-09-26 under 510(k) number K930191. 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 DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY?

DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K930191.

When did DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY receive FDA 510(k) clearance?

DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY received FDA 510(k) clearance on 1995-09-26, under 510(k) number K930191.

Who is the listed applicant for DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY?

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

What is the FDA product code for DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY?

The FDA product code for DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY is HRX.

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Other records listing Sofamor Danek Mfg., Inc. as applicant

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Related Devices (Code: 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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