510(k) K183171
K183171 is an FDA 510(k) premarket notification submitted by Gi Scientific, LLC for the device "ScopeSeal Duodenoscope Protective Device". The FDA issued a decision of Substantially Equivalent on October 8, 2019. The device falls under product code ODB (Endoscopic Contamination Prevention Sheath), a Class II device regulated under 21 CFR 876.1500. Gi Scientific, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2019
- Date Received
- November 16, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Contamination Prevention Sheath
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.