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 |