The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Single-site Port.
| Device ID | K133203 |
| 510k Number | K133203 |
| Device Name: | SINGLE-SITE PORT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BLDG. 101 Sunnyvale, CA 94086 -5206 |
| Contact | Einav Yemini |
| Correspondent | Einav Yemini INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BLDG. 101 Sunnyvale, CA 94086 -5206 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-05-09 |
| Summary: | summary |