The following data is part of a premarket notification filed by Nds Surgical Imaging with the FDA for Nds Surgical Imaging, Llc For The Zerowire Duo Wireless Hd Video Transfer System, Model Wu-wx-wy (where U=r Or T, W=p, X.
| Device ID | K100195 |
| 510k Number | K100195 |
| Device Name: | NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NDS SURGICAL IMAGING 5750 HELLYER AVENUE San Jose, CA 95138 |
| Contact | Jim Leng |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851455007676 | K100195 | 000 |
| 00851455007133 | K100195 | 000 |
| 00851455007126 | K100195 | 000 |
| 00851455007119 | K100195 | 000 |
| 00851455007102 | K100195 | 000 |
| 00851455007096 | K100195 | 000 |
| 00851455007089 | K100195 | 000 |
| 00851455007072 | K100195 | 000 |
| 00851455007065 | K100195 | 000 |
| 00851455007058 | K100195 | 000 |
| 00851455007041 | K100195 | 000 |
| 00851455007034 | K100195 | 000 |
| 00851455007027 | K100195 | 000 |
| 00851455007010 | K100195 | 000 |
| 00851455007140 | K100195 | 000 |
| 00851455007157 | K100195 | 000 |
| 00851455007164 | K100195 | 000 |
| 00851455007669 | K100195 | 000 |
| 00851455007652 | K100195 | 000 |
| 00851455007591 | K100195 | 000 |
| 00851455007485 | K100195 | 000 |
| 00851455007478 | K100195 | 000 |
| 00851455007263 | K100195 | 000 |
| 00851455007232 | K100195 | 000 |
| 00851455007225 | K100195 | 000 |
| 00851455007218 | K100195 | 000 |
| 00851455007201 | K100195 | 000 |
| 00851455007195 | K100195 | 000 |
| 00851455007188 | K100195 | 000 |
| 00851455007171 | K100195 | 000 |
| 00851455007003 | K100195 | 000 |