510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914426Substantially Equivalent

Entree Needle

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

K914426 is the FDA 510(k) clearance record for ENTREE NEEDLE, a class II device, cleared for Core Dynamics, Inc. on under FDA product code FHO (Pneumoperitoneum Needle). FDA's definition for product code FHO reads: "For establishment of a pneumoperitoneum in abdomen". FDA records list 23 510(k) clearances for Core Dynamics, Inc., from to . As of , FDA records show no recalls naming K914426.

Clearance record

Decision date
Received
(56 days to decision)
Product code
FHO Pneumoperitoneum Needle
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Core Dynamics, Inc. 11222-4 St. Johns, Jacksonville FL
510(k) summary
Statement
Third party review
No

Clearances, product code FHO

Trailing 12 months

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

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