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510(k) Data Aggregation
K Number
K250140Device Name
Defendo Fujifilm 700 Single Use Cleaning Adapter
Manufacturer
STERIS Corparation
Date Cleared
2025-02-20
(34 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
STERIS Corparation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Defendo Fujifilm 700 Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
Device Description
This device is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.
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K Number
K213412Device Name
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
Manufacturer
STERIS Corparation
Date Cleared
2022-01-21
(94 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
STERIS Corparation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
- 250°F/121°C, 30 minutes Gravity
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 5 minutes Dynamic Air Removal
- 270°F/132°C, 6 minutes Dynamic Air Removal
- 270°F/132°C, 7 minutes Dynamic Air Removal
- 270°F/132°C, 8 minutes Dynamic Air Removal
- 270°F/132°C, 9 minutes Dynamic Air Removal
- 270°F/132°C, 10 minutes Dynamic Air Removal
- 270°F/132°C, 15 minutes Gravity
- 273°F/134°C, 4 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 3 minutes Gravity
- 270°F/132°C, 10 minutes Gravity
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Gravity
- 275°F/135°C, 10 minutes Gravity
Device Description
The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator 5CM is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
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