510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833457Substantially Equivalent

Ethylene Oxide Gas Steriliza Sys II

Ben Venue Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833457 is the FDA 510(k) clearance record for ETHYLENE OXIDE GAS STERILIZA SYS II, a class II device, cleared for Ben Venue Laboratories, Inc. on under FDA product code FLF (Sterilizer, Ethylene-Oxide Gas). FDA records list one 510(k) clearance for Ben Venue Laboratories, Inc. As of , FDA records show no recalls naming K833457.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FLF Sterilizer, Ethylene-Oxide Gas
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Ben Venue Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FLF

Trailing 12 months

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

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