IS4000 Stapler 30 Instrument and Stapler 30 Reloads
FDA 510(k) clearance K152421 · decided 2016-03-04
Clearance details
- K-number
- K152421
- Device name
- IS4000 Stapler 30 Instrument and Stapler 30 Reloads
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-26
- Decision date
- 2016-03-04
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- NAY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intuitive Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| da Vinci Surgical System, Model IS5000 (K261824) | Intuitive Surgical, Inc. | 2026-07-31 |
| da Vinci Firefly Imaging System (K260695) | Intuitive Surgical | 2026-05-22 |
| Senhance Ultrasonic System (K254192) | Asensus Surgical | 2026-05-12 |
| da Vinci Force Feedback Instruments (K253986) | Intuitive Surgical, Inc. | 2026-03-11 |
| da Vinci Surgical System (IS5000) (K251739) | Intuitive Surgical, Inc. | 2026-01-16 |
| da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556) | Intuitive Surgical, Inc. | 2026-01-16 |
| da Vinci SP Surgical System (SP1098) (K252675) | Intuitive Surgical, Inc. | 2025-12-15 |
| da Vinci SP Surgical System (SP1098) (K252069) | Intuitive Surgical, Inc. | 2025-12-02 |
| da Vinci SP Surgical System (SP1098) (K251426) | Intuitive Surgical, Inc. | 2025-10-03 |
| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
| da Vinci Surgical System (IS5000) (K251227) | Intuitive Surgical, Inc. | 2025-09-08 |
| da Vinci SP Surgical System (SP1098) (K251324) | Intuitive Surgical, Inc. | 2025-08-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuit recall (Z-2677-2016) | Intuitive Surgical, Inc. | 2016-08-26 |
| STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical recall (Z-2349-2016) | Intuitive Surgical, Inc. | 2016-08-05 |
| CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive recall (Z-2350-2016) | Intuitive Surgical, Inc. | 2016-08-05 |