STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process
Summary
Plasmapp Co,., Ltd. received 510(k) clearance for STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), a MLR device. Cleared on 2023-04-14.
Details
Source
510(k) Clearance
External ID
K220345
Action Date
2023-04-14
Status
Traditional
Category
device
Product Code
MLR
Product Description
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40). Product code: MLR.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Plasmapp Co,., Ltd. has received 8 total clearances in our database.
Plasmapp Co,., Ltd. has 8 FDA actions in our database, including 8 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Plasmapp Co,., Ltd. have FDA actions?
Plasmapp Co,., Ltd. has 8 FDA actions in our database, including 0 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220345" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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