510(k) K181472
K181472 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products (Asp) for the device "AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor". The FDA issued a decision of Substantially Equivalent on April 23, 2019. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Advanced Sterilization Products (Asp) has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2019
- Date Received
- June 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Cleaning, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- HO
- Submission Type
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).