510(k) K191011
K191011 is an FDA 510(k) premarket notification submitted by Meditech Endoscopy, Ltd. for the device "Scope ProTech". The FDA issued a decision of Substantially Equivalent on May 7, 2019. The device falls under product code OCU (Endoscopic Storage Cover), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2019
- Date Received
- April 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.