FDA.reportPublic FDA data

510(k) K261055

Device
AMSCO 700 Steam Sterilizer
Applicant
STERIS Corporation
510(k) number
K261055
Product code
FLE
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-24
Date received
2026-03-31
Regulation
880.6880
Classification name
Sterilizer, Steam
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Karly Eitzman
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FLE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260254Enbio PROEnbio Group AG2026-02-26
K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)2026-01-22
K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare2025-12-30
K250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.2025-08-14
K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.2025-06-06
K243801FRONT-LINE Field Sterilizer (FL135)Fort Defiance Industries, LLC2025-03-07
K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerMidmark Corporation2024-04-04
K233504Lexa MINI (RIS-303, RIS-305)W&H Sterilization S.R.L.2024-02-08
K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC2023-12-19
K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd.2023-11-27
K232485AMSCO 600 Steam SterilizerSteris2023-09-13
K231489Sturdy Autoclave Super MicromSturdy Industrial Co., Ltd.2023-06-21
K223858Lexa MINI (RIS-303, RIS-305)W&H Sterilization S.R.L.2023-05-05
K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC2023-02-10
K213545Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869Steelco S.P.A.2023-02-02