510(k) K143186
K143186 is an FDA 510(k) premarket notification submitted by Erbe USA, Inc. for the device "Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Erbe USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2014
- Date Received
- November 5, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Irrigation/Suction System
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.