510(k) K133311
K133311 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "ENDOLED". The FDA issued a decision of Substantially Equivalent on July 30, 2014. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2014
- Date Received
- October 28, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Led Light Source
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals