The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endowrist Stapler System.
| Device ID | K113706 |
| 510k Number | K113706 |
| Device Name: | ENDOWRIST STAPLER SYSTEM |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Contact | Meghna Sridharan |
| Correspondent | Meghna Sridharan INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874114827 | K113706 | 000 |
| 00886874104361 | K113706 | 000 |
| 00886874110904 | K113706 | 000 |
| 00886874110928 | K113706 | 000 |
| 00886874111093 | K113706 | 000 |
| 10886874111120 | K113706 | 000 |
| 10886874111137 | K113706 | 000 |
| 00886874111857 | K113706 | 000 |
| 00886874111864 | K113706 | 000 |
| 00886874111871 | K113706 | 000 |
| 10886874112806 | K113706 | 000 |
| 10886874112813 | K113706 | 000 |
| 00886874104330 | K113706 | 000 |