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FDA 510(k)

ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE

K-Number: K071903 · 2007-08-02

ApplicantVision-Sciences, Inc.
Decision Date2007-08-02
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE 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 2007-08-02 under 510(k) number K071903. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE?

ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE is a medical device that received FDA 510(k) clearance on 2007-08-02. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K071903.

When did ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE receive FDA 510(k) clearance?

ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE received FDA 510(k) clearance on 2007-08-02, under 510(k) number K071903.

Who is the listed applicant for ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE?

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 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE?

The FDA product code for ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE is EOX.

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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: EOX)

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.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

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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