510(k) K230560
K230560 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "enspire 300 Series Automated Endoscope Reprocessor System". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code NZA (Accessories, Germicide, Cleaning, For Endoscopes), a Class II device regulated under 21 CFR 876.1500. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2023
- Date Received
- February 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Germicide, Cleaning, For Endoscopes
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- HO
- Submission Type
High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).