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FDA 510(k)

VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM

K-Number: K040215 · 2004-04-15

ApplicantVision-Sciences, Inc.
Decision Date2004-04-15
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM 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 2004-04-15 under 510(k) number K040215. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM?

VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-15. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K040215.

When did VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM receive FDA 510(k) clearance?

VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM received FDA 510(k) clearance on 2004-04-15, under 510(k) number K040215.

Who is the listed applicant for VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM?

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-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM?

The FDA product code for VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM is FAJ.

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Other records listing Vision-Sciences, Inc. as applicant

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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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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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