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FDA 510(k)

SINUSCOPE AND BACCESSORIES

K-Number: K002214 · 2000-11-21

ApplicantPollux Endoscopy, Inc.
Decision Date2000-11-21
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUSCOPE AND BACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Pollux Endoscopy, Inc.. It received FDA 510(k) clearance on 2000-11-21 under 510(k) number K002214. 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 SINUSCOPE AND BACCESSORIES?

SINUSCOPE AND BACCESSORIES is a medical device that received FDA 510(k) clearance on 2000-11-21. The listed applicant is Pollux Endoscopy, Inc.. The 510(k) number is K002214.

When did SINUSCOPE AND BACCESSORIES receive FDA 510(k) clearance?

SINUSCOPE AND BACCESSORIES received FDA 510(k) clearance on 2000-11-21, under 510(k) number K002214.

Who is the listed applicant for SINUSCOPE AND BACCESSORIES?

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

What is the FDA product code for SINUSCOPE AND BACCESSORIES?

The FDA product code for SINUSCOPE AND BACCESSORIES 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.

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Other records listing Pollux Endoscopy, 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.

K960872CYSTOSCOPE 0/15/30/70 DEGREESK953484POLLUX OA/POLLUX 30A/POLLUX 70AK943662LAPARASCOPE

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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