The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for 8mm Trocar Kit.
| Device ID | K133845 |
| 510k Number | K133845 |
| Device Name: | 8MM TROCAR KIT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen INTUITIVE SURGICAL 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-18 |
| Decision Date | 2014-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30886874112541 | K133845 | 000 |
| 30886874112510 | K133845 | 000 |
| 30886874112503 | K133845 | 000 |