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FDA 510(k)

ENDOSCOPE SHEATH

K-Number: K940028 · 1995-03-24

ApplicantXomed-Treace, Inc.
Decision Date1995-03-24
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K940028. 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 ENDOSCOPE SHEATH?

ENDOSCOPE SHEATH is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K940028.

When did ENDOSCOPE SHEATH receive FDA 510(k) clearance?

ENDOSCOPE SHEATH received FDA 510(k) clearance on 1995-03-24, under 510(k) number K940028.

Who is the listed applicant for ENDOSCOPE SHEATH?

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

What is the FDA product code for ENDOSCOPE SHEATH?

The FDA product code for ENDOSCOPE SHEATH is EOB.

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Other records listing Xomed-Treace, 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.

K941407TYMPANOSTOMY (VENTILATION) TUBEK945659BLACKSTAR(TM) STAR SYSTEMK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPE

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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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