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FDA 510(k)

FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM

K-Number: K921690 · 1992-10-28

ApplicantVision-Sciences, Inc.
Decision Date1992-10-28
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE 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 1992-10-28 under 510(k) number K921690. 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 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM?

FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1992-10-28. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K921690.

When did FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM receive FDA 510(k) clearance?

FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM received FDA 510(k) clearance on 1992-10-28, under 510(k) number K921690.

Who is the listed applicant for FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE 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 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM?

The FDA product code for FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM 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

View all 33 devices →

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.K964100VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100Vision-Sciences, Inc.K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPEVision-Sciences, Inc.K961567ES-3840, 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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