FDA 510(k)

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

N.º K: K250802 · 2025-04-14

SolicitanteAdvanced Sterilization Products, Inc.

Fecha de decisión2025-04-14

Código de productoMLR

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) 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 2025-04-14 under 510(k) number K250802. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)?

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) is a medical device that received FDA 510(k) clearance on 2025-04-14. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K250802.

When did STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) receive FDA 510(k) clearance?

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) received FDA 510(k) clearance on 2025-04-14, under 510(k) number K250802.

Who is the listed applicant for STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)?

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® 100NX Sterilizer with ALLClear™ Technology (10104)?

The FDA product code for STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) is MLR.

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Otros registros que enlistan a Advanced Sterilization Products, Inc. como solicitante

K252843STERRAD 100NX Sterilization System 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)K220404STERRAD NX with ALLClear Technology K212174STERRAD 100NX Sterilizer with ALLClear Technology

Dispositivos relacionados (Código: MLR)

K252843STERRAD 100NX Sterilization System 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 K223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation

Fuente oficial

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