Cleared Traditional

STERLINK? FPS-15s Plus sterilizer with STERPACK? plus cassette

K223015 · Plasmapp Co,., Ltd. · General Hospital
May 2023
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K223015 is an FDA 510(k) clearance for the STERLINK? FPS-15s Plus sterilizer with STERPACK? plus cassette, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on May 9, 2023, 222 days after receiving the submission on September 29, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K223015 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date May 09, 2023
Days to Decision 222 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MLR — Sterilizer, Chemical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6860

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