Tyvek Roll with CI for STERLINK Sterilizer— 510(k) K223025

Clearance details

Applicant

Plasmapp Co,., Ltd.

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

2022-09-29

Decision date

2023-05-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Daejeon, KR

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• K251347 — Sterilization Pouch/Roll2026-01-28
• K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

• K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2023-05-25
• K223015 — STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette2023-05-09
• K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2023-05-09
• K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer +1 more2023-04-14
• K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)2021-10-22

Other

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →