510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963795Substantially Equivalent

Vision-Sciences Model B-F100 Bronchoscope with Model Bs-F21 Disposable Endosheath

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

K963795 is the FDA 510(k) clearance record for VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH, a class II device, cleared for Vision-Sciences, Inc. on under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the...". FDA records list 35 510(k) clearances for COGENTIX MEDICAL, INC., from to . As of , FDA records show no recalls naming K963795.

Clearance record

Decision date
Received
(91 days to decision)
Product code
EOQ Bronchoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Vision-Sciences, Inc. 6 Strathmore Rd., Natick MA
510(k) summary
Summary
Third party review
No

Clearances, product code EOQ

Trailing 12 months
11 clearances under product code EOQ in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EOQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20262
May 20261
June 20261
July 20262
August 20260
September 20263
October 20260