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FDA 510(k)

VISION SYSTEM UPPER G.I. EXDOSCOPE

K-Number: K943715 · 1995-02-24

ApplicantVision-Sciences, Inc.
Decision Date1995-02-24
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VISION SYSTEM UPPER G.I. EXDOSCOPE 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 1995-02-24 under 510(k) number K943715. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISION SYSTEM UPPER G.I. EXDOSCOPE?

VISION SYSTEM UPPER G.I. EXDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K943715.

When did VISION SYSTEM UPPER G.I. EXDOSCOPE receive FDA 510(k) clearance?

VISION SYSTEM UPPER G.I. EXDOSCOPE received FDA 510(k) clearance on 1995-02-24, under 510(k) number K943715.

Who is the listed applicant for VISION SYSTEM UPPER G.I. EXDOSCOPE?

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 VISION SYSTEM UPPER G.I. EXDOSCOPE?

The FDA product code for VISION SYSTEM UPPER G.I. EXDOSCOPE is FDS.

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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

View all 33 devices →

Related Devices (Code: FDS)

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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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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