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FDA 510(k)

VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100

K-Number: K964100 · 1996-12-16

ApplicantVision-Sciences, Inc.
Decision Date1996-12-16
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 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 1996-12-16 under 510(k) number K964100. The device is classified under product code FAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100?

VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K964100.

When did VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 receive FDA 510(k) clearance?

VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 received FDA 510(k) clearance on 1996-12-16, under 510(k) number K964100.

Who is the listed applicant for VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100?

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 MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100?

The FDA product code for VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 is FAM.

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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: FAM)

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.

K964131ENDOSCOPEAkos Biomedical, Inc.K970382VS-100 VIDEO SIGMOIDOSCOPEWelch Allyn, Inc.K964326VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPEVision-Sciences, Inc.K961567ES-3840, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.K951577ES-3800, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.

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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