FDA 510(k)

STERRAD NX with ALLClear Technology

Número K: K220404 · 2022-05-16

RequerenteAdvanced Sterilization Products, Inc.

Data da decisão2022-05-16

Código do produtoMLR

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

STERRAD NX with ALLClear Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K220404. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STERRAD NX with ALLClear Technology?

STERRAD NX with ALLClear Technology is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K220404.

When did STERRAD NX with ALLClear Technology receive FDA 510(k) clearance?

STERRAD NX with ALLClear Technology received FDA 510(k) clearance on 2022-05-16, under 510(k) number K220404.

Who is the listed applicant for STERRAD NX with ALLClear Technology?

The FDA 510(k) record lists Advanced Sterilization Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD NX with ALLClear Technology?

The FDA product code for STERRAD NX with ALLClear Technology is MLR.

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Outros registros que listam Advanced Sterilization Products, Inc. como candidato(a)

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)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)K212174STERRAD 100NX Sterilizer with ALLClear Technology

Dispositivos Relacionados (Código: MLR)

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization Products K233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris

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