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FDA 510(k)

ENDIUS SUCTION/IRRIGATION INSTRUMENT

K-Number: K992535 · 1999-09-01

ApplicantEndius, Inc.
Decision Date1999-09-01
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDIUS SUCTION/IRRIGATION INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Endius, Inc.. It received FDA 510(k) clearance on 1999-09-01 under 510(k) number K992535. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDIUS SUCTION/IRRIGATION INSTRUMENT?

ENDIUS SUCTION/IRRIGATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Endius, Inc.. The 510(k) number is K992535.

When did ENDIUS SUCTION/IRRIGATION INSTRUMENT receive FDA 510(k) clearance?

ENDIUS SUCTION/IRRIGATION INSTRUMENT received FDA 510(k) clearance on 1999-09-01, under 510(k) number K992535.

Who is the listed applicant for ENDIUS SUCTION/IRRIGATION INSTRUMENT?

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 SUCTION/IRRIGATION INSTRUMENT?

The FDA product code for ENDIUS SUCTION/IRRIGATION INSTRUMENT is OCX.

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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: OCX)

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.

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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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