510(k) K111788
K111788 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "ENDOEYE HD II". The FDA issued a decision of Substantially Equivalent on January 13, 2012. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Olympus America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2012
- Date Received
- June 24, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type