510(k) K151609
K151609 is an FDA 510(k) premarket notification submitted by Nds Surgical Imaging, LLC for the device "ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2". The FDA issued a decision of Substantially Equivalent on Nov 6, 2015. The device falls under product code GCJ (Laparoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500. Nds Surgical Imaging, LLC has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 6, 2015
- Date Received
- Jun 15, 2015
- 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).