Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPTUS SINUSCOPES AND ACCESSORIES

K-Number: K944656 · 1995-01-26

ApplicantOptus, Inc.
Decision Date1995-01-26
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPTUS SINUSCOPES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1995-01-26 under 510(k) number K944656. 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 OPTUS SINUSCOPES AND ACCESSORIES?

OPTUS SINUSCOPES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-01-26. The listed applicant is Optus, Inc.. The 510(k) number is K944656.

When did OPTUS SINUSCOPES AND ACCESSORIES receive FDA 510(k) clearance?

OPTUS SINUSCOPES AND ACCESSORIES received FDA 510(k) clearance on 1995-01-26, under 510(k) number K944656.

Who is the listed applicant for OPTUS SINUSCOPES AND ACCESSORIES?

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

What is the FDA product code for OPTUS SINUSCOPES AND ACCESSORIES?

The FDA product code for OPTUS SINUSCOPES AND ACCESSORIES is EOB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Optus, 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.

K945264OPTUS OTOSCOPESK953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESK945268OPTUS BRONCHOSCOPESK945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES

View all 10 devices →

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

View on FDA Database →

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

↑