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FDA 510(k)

DISPOSABLE PROTECTIVE SHEATH

K-Number: K921244 · 1992-10-06

ApplicantVision-Sciences, Inc.
Decision Date1992-10-06
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PROTECTIVE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Vision-Sciences, Inc.. It received FDA 510(k) clearance on 1992-10-06 under 510(k) number K921244. 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 DISPOSABLE PROTECTIVE SHEATH?

DISPOSABLE PROTECTIVE SHEATH is a medical device that received FDA 510(k) clearance on 1992-10-06. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K921244.

When did DISPOSABLE PROTECTIVE SHEATH receive FDA 510(k) clearance?

DISPOSABLE PROTECTIVE SHEATH received FDA 510(k) clearance on 1992-10-06, under 510(k) number K921244.

Who is the listed applicant for DISPOSABLE PROTECTIVE SHEATH?

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

What is the FDA product code for DISPOSABLE PROTECTIVE SHEATH?

The FDA product code for DISPOSABLE PROTECTIVE SHEATH is EOB.

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Other records listing Vision-Sciences, 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.

K102733VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSORK100125VISION SCIENCES FLEXIBLE ENT SCOPEK091768VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIESK072180VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEMK071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEMK072088FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS

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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

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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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