# K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 4, 2016 after 191 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033269 (2003). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140553: Endowrist Stapler 45 and Stapler 45 Reloads, Intuitive Surgical, Inc. (2014) Summary page 4.
- K033269: Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge Reload, Ethicon Endo-Surgery, Inc. (2003) Summary page 4.

## Most influential descendants
- K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (2017), 12 descendants of its own
- K173721: SureForm 60 and SureForm 60 Reloads (2018), 6 descendants of its own
- K183224: SureForm 45, SureForm 45 Reloads (2019), 5 descendants of its own
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload (2019), 4 descendants of its own
- K181395: Universal Cannula Seal (5-12 mm) (2018), 4 descendants of its own

## Recalls of this device
- Jul 14, 2016 · Class II · Z-2349-2016: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increas
- Jul 14, 2016 · Class II · Z-2350-2016: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increas
- Jul 14, 2016 · Class II · Z-2677-2016: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.

## Indications for use
The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

Source page: https://510kreport.com/device/K152421
Methodology: https://510kreport.com/methodology