# K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 8, 2011 after 129 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K930667 (1994). 72 ancestors in all.
43 later devices descend from it; 4 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)
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009)
- K082619: Sils Port, Models SILSPT5, SILSPT12, Covidien Lp, Formerly Registered AS United States (2008) Summary page 1.
- K091697: Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015, Transenterix, Inc. (2009) Summary page 1.
- K102646: Spider Flex Monopolar Hook, Transenterix, Inc. (2010) Summary page 1.
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003, Transenterix, Inc. (2009) Summary page 1.

## Most influential descendants
- K120215: Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single-Site Crocodile (2012), 42 descendants of its own
- 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

## Recalls of this device
- Aug 8, 2015 · Class II · Z-2756-2015: 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-2757-2015: 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-2752-2015: 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-2753-2015: 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-2750-2015: 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-2758-2015: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
- Mar 13, 2014 · Class II · Z-1333-2014: Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site label
- Mar 13, 2014 · Class II · Z-1332-2014: Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site label
- Mar 13, 2014 · Class II · Z-1335-2014: Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site label
- Mar 13, 2014 · Class II · Z-1334-2014: Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site label
- Oct 2, 2013 · Class II · Z-0110-2014: A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added i
- Oct 2, 2013 · Class II · Z-0111-2014: A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added i

## Indications for use
The Intuitive Surgical do Vinci Single-Site Instruments and Accessories used with the do Vinci Si Surgical System (153000) 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 electrocoutery during single incision laparoscopic cholecysteclomy with the do Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 1Omm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

Source page: https://510kreport.com/device/K112208
Methodology: https://510kreport.com/methodology