FDA 510(k)
Unknown
🇺🇸 United States
Prolystica Pass Thru Disinfectant Wipes
K Number: DEN240075
·
Decision May 1, 2026
Classifications
0
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
21
Review Days
505
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Basic Information
- Device Name
- Prolystica Pass Thru Disinfectant Wipes
- K Number
- DEN240075
- Clearance Type
- Direct
- Decision
- Unknown
- Applicant
- Steris
- Date Received
- December 12, 2024
- Decision Date
- May 1, 2026
- Product Code
- SHM
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- Third Party
- N
Other Clearances by Steris
| K Number | Device Name | ||
|---|---|---|---|
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Jun 6, 2025 | Substantially Equivalent |
| K242773 | Electro Lube NXT | Apr 15, 2025 | Substantially Equivalent |
| DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | Nov 12, 2024 | Unknown |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Aug 20, 2024 | Substantially Equivalent |
| K241344 | MetriCide OPA Plus Solution Test Strip | Jun 11, 2024 | Substantially Equivalent |
| K241055 | Electro Lube NXT | May 31, 2024 | Substantially Equivalent |
| K240760 | CELERITY HP Indicator Tape | Apr 10, 2024 | Substantially Equivalent |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | Mar 8, 2024 | Substantially Equivalent |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Dec 8, 2023 | Substantially Equivalent |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Oct 27, 2023 | Substantially Equivalent |