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510(k) K162758

Device
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
Applicant
STERIS Corporation
510(k) number
K162758
Product code
JOJ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-03-21
Date received
2016-09-30
Regulation
880.2800
Classification name
Indicator, Physical/chemical Sterilization Process
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anthony Piotrkowski
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 JOJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group2026-02-20
K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2025-12-23
K251035DISINTEK™ PA Test StripsSerim Research2025-06-03
K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation2025-05-02
K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation2025-04-25
K250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)2025-02-20
K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLC2025-01-17
K241036Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd.2024-12-17
K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation2024-12-04
K242795Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg. (A Getinge Group Company)2024-10-15
K241836Kem Medical Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corporation2024-09-30
K242189CELERITY HP Indicator Tape (PCC077)Steris2024-08-20
K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)Advanced Sterilization Products, Inc.2024-07-05
K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC2024-06-26
K240910EO Chex Indicator TapePropper Manufacturing Co., Inc.2024-06-12

Legacy Summary#

summary

FDA Review#

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