510(k) K103696
K103696 is an FDA 510(k) premarket notification submitted by Erbe USA, Inc. for the device "ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES". The FDA issued a decision of Substantially Equivalent on March 22, 2011. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), 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
- March 22, 2011
- Date Received
- December 17, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Air, Non-Manual, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type