Cleared Traditional

Terragene? Bionova? Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene? Bionova? Photon Process Challenge Device with moving-front integrator (PCD225-C)

K242453 · Terragene S.A. · General Hospital
Dec 2024
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K242453 is an FDA 510(k) clearance for the Terragene? Bionova? Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene? Bionova? Photon Process Challenge Device with moving-front integrator (PCD225-C), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on December 12, 2024, 115 days after receiving the submission on August 19, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K242453 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2024
Decision Date December 12, 2024
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRC — Indicator, Biological Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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