Submission Details
| 510(k) Number | K231169 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 2023 |
| Decision Date | May 25, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
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)
May 2023
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K231169 is an FDA 510(k) clearance for the 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), 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 25, 2023, 30 days after receiving the submission on April 25, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.
Device Classification
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6860 |
Manufacturer
Similar Devices — MLR Sterilizer, Chemical
All 45
K250802 · Advanced Sterilization Products, Inc.
· Apr 2025
K231893 · Lowtem Co., Ltd.
· Sep 2024
K234082 · Advanced Sterilization Products
· Jul 2024
K233762 · Ideate Medical, Inc.
· Jun 2024
K233065 · Steris
· Oct 2023
K223476 · STERIS Corporation
· Aug 2023
More from Plasmapp Co,., Ltd.
View all
K223015
· MLR · May 2023
K223023
· FRC · May 2023
K223025
· FRG · May 2023
K220345
· MLR · Apr 2023
K212193
· FRC · Oct 2021