510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980917Substantially Equivalent

All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes and Cwv Reservoir

Fortune Medical Instrument Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980917 is the FDA 510(k) clearance record for ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR, a class II device, cleared for Fortune Medical Instrument Corp. on under FDA product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection). FDA records list 6 510(k) clearances for Fortune Medical Instrument Corp., from to . As of , FDA records show no recalls naming K980917.

Clearance record

Decision date
Received
(77 days to decision)
Product code
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fortune Medical Instrument Corp. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code GCA

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