Prolystica Pass Thru Disinfectant Wipes
Summary
Steris received 510(k) clearance for Prolystica Pass Thru Disinfectant Wipes, a SHM device. Cleared on 2026-05-01.
Details
Source
510(k) Clearance
External ID
DEN240075
Action Date
2026-05-01
Status
Direct
Category
device
Product Code
SHM
Product Description
Prolystica Pass Thru Disinfectant Wipes. Product code: SHM.
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. Steris has received 18 total clearances in our database.
Steris has 18 FDA actions in our database, including 18 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 Steris have FDA actions?
Steris has 18 FDA actions in our database, including 0 recalls and 18 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN240075" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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