FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH— 510(k) K932843

Name: FDA 510(k) clearance K932843
Creator: U.S. Food and Drug Administration
Published: 1994-02-14

Substantially Equivalent

Vision-Sciences, Inc.

FDA 510(k) clearance K932843 for FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH, Substantially Equivalent on 1994-02-14. Applicant: Vision-Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Vision-Sciences, Inc.
Product code: Code FAM
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-11
Decision date: 1994-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAM

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K964131 — ENDOSCOPE1997-06-27
K970382 — VS-100 VIDEO SIGMOIDOSCOPE1997-04-17
K964326 — VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM1997-01-03
K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V1001996-12-16
K963344 — DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE1996-11-21

More clearances from Vision-Sciences, Inc.

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K102733 — VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR2011-05-18
K100125 — VISION SCIENCES FLEXIBLE ENT SCOPE2010-02-25
K091768 — VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES2009-08-03
K072180 — VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM2007-12-18
K071127 — FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM2007-11-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.