# K253986: da Vinci Force Feedback Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 11, 2026 after 89 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: 27 generations back to K930667 (1994). 146 ancestors in all.
No later device cites it as a predicate yet.
3 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243641: da Vinci Surgical System (IS5000), Intuitive Surgical, Inc. (2024) Summary page 5.

## Indications for use
The da Vinci Force Feedback Instruments are 8 mm, multi-use endoscopic instruments intended to be used with the da Vinci Surgical System, Model IS5000. These instruments have an articulating wrist that gives surgeons natural dexterity and range of motion, and possess the ability to render forces measured at the instrument tip to the hand controls at the Surgeon Console of the IS5000 System. Each instrument performs one or more surgical tasks such as suturing,grasping, and tissue manipulation. Indications for use of the da Vinci Force Feedback Instruments are covered as part of the da Vinci Surgical System, Model IS5000. The most recent cleared indications for use, which are not anticipated to be modified in the upcoming 510(k), are listed for reference below. Da Vinci Surgical System, Model IS5000: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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 and general thoracoscopic surgical procedures. The system is indicated for adult use. 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. Contraindication: Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturino in these procedures.

Source page: https://510kreport.com/device/K253986
Methodology: https://510kreport.com/methodology