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FDA 510(k)

ENDOSCOPIC SPINAL ACCESS SYSTEM

K-Number: K991794 · 1999-08-13

ApplicantEndius, Inc.
Decision Date1999-08-13
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC SPINAL ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endius, Inc.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K991794. 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 ENDOSCOPIC SPINAL ACCESS SYSTEM?

ENDOSCOPIC SPINAL ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Endius, Inc.. The 510(k) number is K991794.

When did ENDOSCOPIC SPINAL ACCESS SYSTEM receive FDA 510(k) clearance?

ENDOSCOPIC SPINAL ACCESS SYSTEM received FDA 510(k) clearance on 1999-08-13, under 510(k) number K991794.

Who is the listed applicant for ENDOSCOPIC SPINAL ACCESS SYSTEM?

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 ENDOSCOPIC SPINAL ACCESS SYSTEM?

The FDA product code for ENDOSCOPIC SPINAL ACCESS SYSTEM is HRX.

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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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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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