The following data is part of a premarket notification filed by Nds Surgical Imaging Llc with the FDA for Zerowire Duo Wireless Hd Video Transfer System G2 Or Zerowire G2.
| Device ID | K151609 |
| 510k Number | K151609 |
| Device Name: | ZeroWire Duo Wireless HD Video Transfer System G2 Or ZeroWire G2 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NDS SURGICAL IMAGING LLC 5750 HELLYER AVENUE San Jose, CA 95138 |
| Contact | Jim Leng |
| Correspondent | Jim Leng NDS SURGICAL IMAGING LLC 5750 HELLYER AVENUE San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2015-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818089020297 | K151609 | 000 |
| 00818089022796 | K151609 | 000 |
| 00818089022710 | K151609 | 000 |
| 00818089022727 | K151609 | 000 |
| 00818089022734 | K151609 | 000 |
| 00851455007607 | K151609 | 000 |
| 00851455007614 | K151609 | 000 |
| 00851455007713 | K151609 | 000 |
| 00851455007744 | K151609 | 000 |
| 00851455007751 | K151609 | 000 |
| 00851455007768 | K151609 | 000 |
| 00818089020259 | K151609 | 000 |
| 00818089020266 | K151609 | 000 |
| 00818089022789 | K151609 | 000 |