510(k) K203223
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2021
- Date Received
- November 2, 2020
- 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).