# K170875: da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 12, 2017 after 172 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930667 (1994). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122532: DA Vinci Single-Site Instruments and Accessories, Intuitive Surgical, Inc. (2013) Summary page 5.
- K130726: DA Vinci Single-Site Permanent Cautery Hook, Intuitive Surgical, Inc. (2013) Summary page 5.
- K141075: Single-Site Wristed Needle Driver, Intuitive Surgical (2014) Summary page 5.
- K152448: da Vinci Single-Site Instrument and Accessories, Intuitive Surgical, Inc. (2016) Summary page 6.

## 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, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port. The Intuitive Surgical da Vinci® Xi™ Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) 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, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

Source page: https://510kreport.com/device/K170875
Methodology: https://510kreport.com/methodology