The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for 5mm Flared Cannula Model 420262, 8mm Flared Cannula Model 420319.
| Device ID | K101743 |
| 510k Number | K101743 |
| Device Name: | 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Karen Uyesugi |
| Correspondent | Karen Uyesugi INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-22 |
| Decision Date | 2011-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874111819 | K101743 | 000 |
| 00886874111741 | K101743 | 000 |