The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Neoscope 3d - 3d Digital Video Endoscopic System (rigid/flexible).
| Device ID | K152619 |
| 510k Number | K152619 |
| Device Name: | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2016-04-29 |
| Summary: | summary |