# K120215: Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single-Site Crocodile

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 30, 2012 after 97 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: 12 generations back to K930667 (1994). 73 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories, Intuitive Surgical, Inc. (2011) Summary page 1.

## Most influential descendants
- K122532: DA Vinci Single-Site Instruments and Accessories (2013), 39 descendants of its own
- K131962: DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories (2014), 22 descendants of its own
- K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2018), 21 descendants of its own
- K182371: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2019), 20 descendants of its own
- K202571: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (2020), 14 descendants of its own

## Recalls of this device
- Aug 8, 2015 · Class II · Z-2755-2015: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
- Aug 8, 2015 · Class II · Z-2751-2015: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
- Aug 8, 2015 · Class II · Z-2754-2015: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.

## Indications for use
The Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

Source page: https://510kreport.com/device/K120215
Methodology: https://510kreport.com/methodology