510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911813Substantially Equivalent

Entree Cannula

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

K911813 is the FDA 510(k) clearance record for ENTREE CANNULA, a class I device, cleared for Core Dynamics, Inc. on under FDA product code FBM (Cannula And Trocar, Suprapubic, Non-Disposable). FDA records list 23 510(k) clearances for Core Dynamics, Inc., from to . As of , FDA records show no recalls naming K911813.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FBM Cannula And Trocar, Suprapubic, Non-Disposable
Regulation
21 CFR 876.5090
Device class
Class I
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 FBM

Trailing 12 months

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

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