IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
FDA 510(k) K170879 · Intuitive Surgical, Inc.
510(k) numberK170879
Submission
- Device name
- IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
- Applicant
- Intuitive Surgical, Inc.
Sunnyvale, CA, US - Received
- March 24, 2017
- Decision date
- September 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code NAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 09/08/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 07/31/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | Intuitive Surgical | 05/22/2026SE |
| K254192 | Senhance Ultrasonic SystemNAY · Traditional | Asensus Surgical | 05/12/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 03/11/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/15/2025SE |
| K252069 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/02/2025SE |
| K251426 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 10/03/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | 08/07/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K251763 | IRISegQIH · Traditional | 12/16/2025SE |
Questions and answers
When was IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories cleared by the FDA?
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories (K170879) received a 510(k) decision of Substantially Equivalent on September 21, 2017, 181 days after the submission was received.
What is the product code of K170879?
The FDA product code is NAY – System, Surgical, Computer Controlled Instrument, a Class II (moderate risk) device regulated under 21 CFR 876.1500.