# K122532: DA Vinci Single-Site Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 30, 2013 after 344 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K930667 (1994). 78 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 118 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.
- K120215: Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single-Site Crocodile, Intuitive Surgical, Inc. (2012) Summary page 1.
- K091869: Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears, Covidien Lp, Formerly Registered AS United States (2009) Summary page 1.
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009) Summary page 1.
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 1.
- (no number) SILS Port and manual single-incision instruments: named in the summary without a submission number

## Most influential descendants
- 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
- K230033: Da Vinci SP Surgical System (SP1098) (2023), 12 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.

## Indications for use
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (1S3000) 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 5 mm Single-Site Port.

Source page: https://510kreport.com/device/K122532
Methodology: https://510kreport.com/methodology