510(k) K190744
K190744 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)". The FDA issued a decision of Substantially Equivalent on August 29, 2019. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2019
- Date Received
- March 22, 2019
- Clearance Type
- Special
- 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