510(k) K151191
K151191 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "OES ELITE Telescopes, Protective Tube". The FDA issued a decision of Substantially Equivalent on November 24, 2015. The device falls under product code FBP (Telescope, Rigid, Endoscopic), 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
- November 24, 2015
- Date Received
- May 4, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Telescope, Rigid, Endoscopic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type