510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953719Substantially Equivalent

Human Tubal Fluid

Life Technologies Corporation, Grand Island NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953719 is the FDA 510(k) clearance record for HUMAN TUBAL FLUID, a class II device, cleared for Life Technologies, Inc. on under FDA product code MFD (Cannula, Intrauterine Insemination). FDA records list 11 510(k) clearances for Life Technologies, Inc., from to . As of , FDA records show no recalls naming K953719.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MFD Cannula, Intrauterine Insemination
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Life Technologies, Inc. 3175 Staley Rd., Grand Island NY
510(k) summary
Summary
Third party review
No

Clearances, product code MFD

Trailing 12 months

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

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