510(k) K983017
K983017 is an FDA 510(k) premarket notification submitted by Custom Ultrasonics for the device "MODIFICATION TO SYSTEM 83 PLUS". The FDA issued a decision of Substantially Equivalent on September 22, 1998. The device falls under product code NVE (Washer, Cleaner, Automated, Endoscope), a Class II device regulated under 21 CFR 876.1500. Custom Ultrasonics has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1998
- Date Received
- August 28, 1998
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Cleaner, Automated, Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- HO
- Submission Type
This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. 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). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the endoscopes.