510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930512Substantially Equivalent

Suction/irrigation Y Tubing Set W/trumpet Valves

Core Dynamics, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930512 is the FDA 510(k) clearance record for SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES, a class II device, cleared for Core Dynamics, Inc. on under FDA product code GAZ (Tubing, Noninvasive). FDA records list 23 510(k) clearances for Core Dynamics, Inc., from to . As of , FDA records show one recall naming K930512.

Clearance record

Decision date
Received
(172 days to decision)
Product code
GAZ Tubing, Noninvasive
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Core Dynamics, Inc. 11222-4 St. Johns, Jacksonville FL
510(k) summary
Statement
Third party review
No

Clearances, product code GAZ

Trailing 12 months

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

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