# K243968: Revolve Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Revolve Surgical, Inc.
- Decided: Oct 3, 2025 after 284 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 5 generations back to K912544 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173919: HX Device, Human Extension, Ltd. (2018) Summary page 5.

## Indications for use
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.

Source page: https://510kreport.com/device/K243968
Methodology: https://510kreport.com/methodology