The following data is part of a premarket notification filed by Nds Surgical Imaging, Llc. with the FDA for Zerowire Mobile.
| Device ID | K170598 |
| 510k Number | K170598 |
| Device Name: | ZeroWire Mobile |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NDS Surgical Imaging, LLC. 5750 Hellyer Ave San Jose, CA 95138 |
| Contact | Shala Famil |
| Correspondent | Shelley Trimm RCQ Consulting Services 1152 Navarro Street Santa Rosa, CA 95401 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-04-07 |
| Summary: | summary |