The following data is part of a premarket notification filed by Virtual Ports Ltd with the FDA for Endoclear System.
| Device ID | K100346 |
| 510k Number | K100346 |
| Device Name: | ENDOCLEAR SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VIRTUAL PORTS LTD 31 HAAVODA STREET Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy VIRTUAL PORTS LTD 31 HAAVODA STREET Binyamina, IL 30500 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-03-10 |
| Summary: | summary |