510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011598Substantially Equivalent

Water for Assisted Reproductive Technologies (A.r.t.) Use

FUJIFILM Biosciences Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011598 is the FDA 510(k) clearance record for WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE, a class II device, cleared for Irvine Scientific Sales Co., Inc. on under FDA product code MTW (System, Water, Reproduction, Assisted, And Purification). FDA records list 45 510(k) clearances for FUJIFILM Biosciences INC., from to . As of , FDA records show no recalls naming K011598.

Clearance record

Decision date
Received
(20 days to decision)
Product code
MTW System, Water, Reproduction, Assisted, And Purification
Regulation
21 CFR 884.6170
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Irvine Scientific Sales Co., Inc. 2511 Daimler St., Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code MTW

Trailing 12 months

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

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