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FDA 510(k)

ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM

K-Number: K946011 · 1995-02-17

ApplicantArgus Medical Co., Inc.
Decision Date1995-02-17
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Argus Medical Co., Inc.. It received FDA 510(k) clearance on 1995-02-17 under 510(k) number K946011. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM?

ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Argus Medical Co., Inc.. The 510(k) number is K946011.

When did ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM receive FDA 510(k) clearance?

ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM received FDA 510(k) clearance on 1995-02-17, under 510(k) number K946011.

Who is the listed applicant for ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM?

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

What is the FDA product code for ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM?

The FDA product code for ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM is EOB.

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Other records listing Argus Medical Co., 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.

K950255ARGUS HYSTEROSCOPY INSTRUMENT SYSTEMK951624ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEMK950242ARGUS ARTHROSCOPY INSTRUMENT SYSTEMK950297ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEMK950378ARGUS LAPAROSCOPY INSTRUMENT SYSTEM

Related Devices (Code: EOB)

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.

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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