510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885202Substantially Equivalent

16 Long Catheter W/adapter, 14 Fr and 12 Fr

Coeur Laboratories, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885202 is the FDA 510(k) clearance record for 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR, a class II device, cleared for Coeur Laboratories, Inc. on under FDA product code KOD (Catheter, Urological). FDA records list 10 510(k) clearances for Coeur Laboratories, Inc., from to . As of , FDA records show no recalls naming K885202.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Coeur Laboratories, Inc. 5301 Depature Dr., Raleigh NC
Third party review
No

Clearances, product code KOD

Trailing 12 months
1 clearance under product code KOD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260