MN-111

FDA 510(k) K172825 · W&H Sterilization S.R.L.

Substantially Equivalent

510(k) numberK172825

Submission

Device name
MN-111
Applicant
W&H Sterilization S.R.L.
Brusaporto, IT
Received
September 18, 2017
Decision date
May 30, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FLE – Sterilizer, Steam
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6880
Specialty
General Hospital

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K243801FRONT-LINE Field Sterilizer (FL135)FLE · Special Fort Defiance Industries, LLC03/07/2025SE
K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional Midmark Corporation04/04/2024SE
K233504Lexa MINI (RIS-303, RIS-305)FLE · Traditional W&H Sterilization S.R.L.02/08/2024SE
K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated Primus Sterilizer Company, LLC12/19/2023SE

More from Primus Sterilizer Company, LLC

510(k)DeviceDecision
K233504Lexa MINI (RIS-303, RIS-305)FLE · Traditional 02/08/2024SE
K223858Lexa MINI (RIS-303, RIS-305)FLE · Traditional 05/05/2023SE
K213758Lexa PLUS RIS-311FLE · Traditional 08/19/2022SE

Questions and answers

When was MN-111 cleared by the FDA?

MN-111 (K172825) received a 510(k) decision of Substantially Equivalent on May 30, 2018, 254 days after the submission was received.

What is the product code of K172825?

The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.