510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950689Substantially Equivalent

Ucb

Cox Medical Ent., Inc., Ventura CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950689 is the FDA 510(k) clearance record for UCB, a class I device, cleared for Cox Medical Ent., Inc. on under FDA product code MNL (Accessories, Cleaning Brushes, For Endoscope). FDA records list 15 510(k) clearances for Cox Medical Ent., Inc., from to . As of , FDA records show no recalls naming K950689.

Clearance record

Decision date
Received
(20 days to decision)
Product code
MNL Accessories, Cleaning Brushes, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Cox Medical Ent., Inc. 2186 Eastman Ave., Suite 110, Ventura CA
510(k) summary
Statement
Third party review
No

Clearances, product code MNL

Trailing 12 months

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

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