510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014002Substantially Equivalent

All Silicone Supra-Pubia Catheter, Models 4880/4890

Fortune Medical Instrument Corp., Taipei Hsien, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014002 is the FDA 510(k) clearance record for ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890, a class II device, cleared for Fortune Medical Instrument Corp. on under FDA product code KOB (Catheter, Suprapubic (And Accessories)). FDA records list 6 510(k) clearances for Fortune Medical Instrument Corp., from to . As of , FDA records show no recalls naming K014002.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KOB Catheter, Suprapubic (And Accessories)
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fortune Medical Instrument Corp. 12-9, Lin 5, Mao-Chang Village, Taipei Hsien, TW
510(k) summary
Statement
Third party review
No

Clearances, product code KOB

Trailing 12 months

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

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