510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031786Substantially Equivalent

Tne-2000 Esophagoscope with Ecs-D Endosheath System

Cogentix Medical, Inc., Ayer MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031786 is the FDA 510(k) clearance record for TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM, a class II device, cleared for Vision-Sciences, Inc. on under FDA product code EOX (Esophagoscope (Flexible Or Rigid)). FDA's definition for product code EOX reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 35 510(k) clearances for COGENTIX MEDICAL, INC., from to . As of , FDA records show no recalls naming K031786.

Clearance record

Decision date
Received
(56 days to decision)
Product code
EOX Esophagoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4710
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Vision-Sciences, Inc. 5 Whitcomb Ave., Ayer MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EOX

Trailing 12 months

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

FDA records show no clearances under product code EOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EOX, 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