The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endowrist Stapler 45 And Stapler 45 Reloads.
| Device ID | K140553 |
| 510k Number | K140553 |
| Device Name: | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER RD Sunnyvale, CA 94086 |
| Contact | Dawn Chang |
| Correspondent | Dawn Chang 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 | 2014-03-04 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874113912 | K140553 | 000 |
| 00886874103920 | K140553 | 000 |
| 00886874103951 | K140553 | 000 |
| 00886874112427 | K140553 | 000 |
| 00886874112557 | K140553 | 000 |
| 00886874112564 | K140553 | 000 |
| 30886874112572 | K140553 | 000 |
| 00886874112618 | K140553 | 000 |
| 00886874112625 | K140553 | 000 |
| 10886874112820 | K140553 | 000 |
| 10886874112875 | K140553 | 000 |
| 10886874112882 | K140553 | 000 |
| 00886874103890 | K140553 | 000 |