510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964100Substantially Equivalent

Vision-Sciences Model Ss-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic Sigmoidoscope and Vsi S-V100

Cogentix Medical, Inc., Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964100 is the FDA 510(k) clearance record for VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100, a class II device, cleared for Vision-Sciences, Inc. on under FDA product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAM reads: "to examine and perform procedures within the sigmoid (descending) colon". FDA records list 35 510(k) clearances for COGENTIX MEDICAL, INC., from to . As of , FDA records show no recalls naming K964100.

Clearance record

Decision date
Received
(66 days to decision)
Product code
FAM Sigmoidoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vision-Sciences, Inc. 6 Strathmore Rd., Natick MA
510(k) summary
Summary
Third party review
No

Clearances, product code FAM

Trailing 12 months

FDA records hold no clearances under product code FAM in the trailing twelve months.

FDA records show no clearances under product code FAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260