The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Is4000 Stapler 30 Instrument And Stapler 30 Reloads.
| Device ID | K152421 |
| 510k Number | K152421 |
| Device Name: | IS4000 Stapler 30 Instrument And Stapler 30 Reloads |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Manish Patel |
| Correspondent | Manish Patel INTUITIVE SURGICAL, INC. 1266 KIFER ROAD 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 | 2015-08-26 |
| Decision Date | 2016-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874112868 | K152421 | 000 |
| 00886874104019 | K152421 | 000 |
| 00886874104040 | K152421 | 000 |
| 00886874104224 | K152421 | 000 |
| 00886874112700 | K152421 | 000 |
| 00886874112717 | K152421 | 000 |
| 10886874112837 | K152421 | 000 |
| 10886874112844 | K152421 | 000 |
| 10886874112851 | K152421 | 000 |
| 00886874103982 | K152421 | 000 |