# K152448: da Vinci Single-Site Instrument and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 9, 2016 after 195 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K930667 (1994). 79 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 90 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 4.

## Most influential descendants
- K170865: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (2017), 8 descendants of its own
- K173337: Intuitive Surgical EndoWrist Vessel Sealer Extend (2018), 7 descendants of its own
- K183107: Intuitive Surgical Vessel Sealer Extend (2018), 6 descendants of its own
- K191280: E-100 Electrosurgical Generator, SynchroSeal (2019), 4 descendants of its own
- K223039: da Vinci E-200 Electrosurgical Generator (2022), 3 descendants of its own

## Recalls of this device
- Oct 6, 2023 · Class II · Z-0406-2024: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

## Indications for use
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, 8mm endoscope cannula, flexible and rigid blunt obturators, cannula seal. and the Single-Site Port.

Source page: https://510kreport.com/device/K152448
Methodology: https://510kreport.com/methodology