Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PUPEndoscope Maintenance System2Product Code
- FEBAccessories, Cleaning, For Endoscope2Product Code
- NVEWasher, Cleaner, Automated, Endoscope2Product Code
- NZAAccessories, Germicide, Cleaning, For Endoscopes2Product Code
- K232918enspire 300 Series Automated Endoscope Reprocessor2Cleared 510(K)
- K230560enspire 300 Series Automated Endoscope Reprocessor System2Cleared 510(K)
- K220361Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide2Cleared 510(K)
- K203223Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide2Cleared 510(K)
- K200989Reliance Endoscope Processing System2Cleared 510(K)
- K123768RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM2Cleared 510(K)
- K110453RELIANCE ENDOSCOPE PROCESSING SYSTEM2Cleared 510(K)
- K102244RELIANCE ENDOSCOPE PROCESSING SYSTEM2Cleared 510(K)
- K040049THE RELIANCE ENDOSCOPE PROCESSING SYSTEM2Cleared 510(K)
- K860704THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND2Cleared 510(K)
Show All 11 Submissions
- OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist2Product Code
- PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid2Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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enspire 300 Series Automated Endoscope Reprocessor System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230560
- 510(k) Type
- Traditional
- Applicant
- STERIS Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/21/2023
- Days to Decision
- 143 days
- Submission Type
- Summary