510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901413Substantially Equivalent

Core Disposable Insufflation Tubing

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

K901413 is the FDA 510(k) clearance record for CORE DISPOSABLE INSUFFLATION TUBING, a class II device, cleared for Core Dynamics, Inc. on under FDA product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)). FDA records list 23 510(k) clearances for Core Dynamics, Inc., from to . As of , FDA records show no recalls naming K901413.

Clearance record

Decision date
Received
(182 days to decision)
Product code
HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Regulation
21 CFR 884.1300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Core Dynamics, Inc. P.O. Box 16351, Jacksonville FL
Third party review
No

Clearances, product code HES

Trailing 12 months

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

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