510(k) K193026
K193026 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Visera Elite II Video System Center, Visera Elite II Endoeye 3D". The FDA issued a decision of Substantially Equivalent on Apr 3, 2020. The device falls under product code GCJ (Laparoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 3, 2020
- Date Received
- Oct 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, General & Plastic Surgery
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
- 510(k)
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).