510(k) K181811
K181811 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "ReTrace Ureteral Access Sheath". The FDA issued a decision of Substantially Equivalent on Sep 7, 2018. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Coloplast A/S has 139 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 7, 2018
- Date Received
- Jul 6, 2018
- Clearance Type
- Special
- 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
- 510(k)
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.