510(k) K202838
K202838 is an FDA 510(k) premarket notification submitted by Ga Health Company Limited for the device "Andorate Universal Endoscope Tip Guard". The FDA issued a decision of Substantially Equivalent on March 5, 2021. The device falls under product code OCU (Endoscopic Storage Cover), a Class II device regulated under 21 CFR 876.1500. Ga Health Company Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2021
- Date Received
- September 25, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Storage Cover
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.