Model 833HC Vacuum/Gravity Steam Sterilizer

FDA 510(k) K031259 · Getinge USA, Inc.

Substantially Equivalent

510(k) numberK031259

Submission

Device name
Model 833HC Vacuum/Gravity Steam Sterilizer
Applicant
Getinge USA, Inc.
Rochester, NY, US
Received
April 21, 2003
Decision date
May 12, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary 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

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K050664Spor-Test Pa Biological Indicator KitFRC · Special 04/07/2005SE
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K031647Biosign Ssi Biological Test Pack with Instant Readout IntegratorJOJ · Traditional 07/29/2003SE

Questions and answers

When was Model 833HC Vacuum/Gravity Steam Sterilizer cleared by the FDA?

Model 833HC Vacuum/Gravity Steam Sterilizer (K031259) received a 510(k) decision of Substantially Equivalent on May 12, 2003, 21 days after the submission was received.

What is the product code of K031259?

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