# K180033: 8mm Monopolar Curved Scissors

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 6, 2018 after 92 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930667 (1994). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000, Intuitive Surgical, Inc. (2005) Summary page 4.

## Most influential descendants
- K210478: 8mm Monopolar Curved Scissors (2022), 0 descendants of its own

## Recalls of this device
- Dec 9, 2025 · Class II · Z-1696-2026: Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Aug 15, 2018 · Class II · Z-3024-2018: Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft,

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes. blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders. endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology robotic surgical procedures restricted to benign and malignant tumors classified as TT and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology robotic surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Source page: https://510kreport.com/device/K180033
Methodology: https://510kreport.com/methodology