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FDA 510(k)

SINUSCOPE

K-Number: K944186 · 1994-11-07

ApplicantStryker Endoscopy
Decision Date1994-11-07
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K944186. 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?

SINUSCOPE is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Stryker Endoscopy. The 510(k) number is K944186.

When did SINUSCOPE receive FDA 510(k) clearance?

SINUSCOPE received FDA 510(k) clearance on 1994-11-07, under 510(k) number K944186.

Who is the listed applicant for SINUSCOPE?

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

What is the FDA product code for SINUSCOPE?

The FDA product code for SINUSCOPE is EOB.

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Other records listing Stryker Endoscopy 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.

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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.

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