510(k) K230801
K230801 is an FDA 510(k) premarket notification submitted by Neptune Medical, Inc. for the device "Pathfinder Endoscope Overtube with Balloon Device". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Neptune Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2023
- Date Received
- March 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.