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FDA 510(k)

ENDIUS SPINE ENDOSCOPE

K-Number: K982819 · 1999-01-27

ApplicantEndius, Inc.
Decision Date1999-01-27
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENDIUS SPINE ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Endius, Inc.. It received FDA 510(k) clearance on 1999-01-27 under 510(k) number K982819. 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 ENDIUS SPINE ENDOSCOPE?

ENDIUS SPINE ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1999-01-27. The listed applicant is Endius, Inc.. The 510(k) number is K982819.

When did ENDIUS SPINE ENDOSCOPE receive FDA 510(k) clearance?

ENDIUS SPINE ENDOSCOPE received FDA 510(k) clearance on 1999-01-27, under 510(k) number K982819.

Who is the listed applicant for ENDIUS SPINE ENDOSCOPE?

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

What is the FDA product code for ENDIUS SPINE ENDOSCOPE?

The FDA product code for ENDIUS SPINE ENDOSCOPE is GWG.

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Other records listing Endius, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080258MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMK073510ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEMK073267ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMK072840ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEMK070282ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMK070367ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM

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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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