510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140085Substantially Equivalent

Universa Percultaneous Drainage Catheter

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140085 is the FDA 510(k) clearance record for UNIVERSA PERCULTANEOUS DRAINAGE CATHETER, a class II device, cleared for Cook Incorporated on under FDA product code FEW (Catheter, Malecot). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K140085.

Clearance record

Decision date
Received
(309 days to decision)
Product code
FEW Catheter, Malecot
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEW

Trailing 12 months

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

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