# K130726: DA Vinci Single-Site Permanent Cautery Hook

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jun 7, 2013 after 81 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 7 (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). 74 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 77 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.

## Cited in the summary but kept off the family tree
- K122532: DA Vinci Single-Site Instruments and Accessories, Intuitive Surgical, Inc. (2013). Our OCR of the scanned summary read K122532, which FDA decided on Jul 30, 2013, after this device was decided (Jun 7, 2013), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Most influential descendants
- K170875: da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories (2017), 0 descendants of its own
- K133203: Single-Site Port (2014), 0 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-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-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 (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 5 mm Single-Site Port.

Source page: https://510kreport.com/device/K130726
Methodology: https://510kreport.com/methodology