# K143299: Percuvance (R) Percutaneous Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jan 21, 2015 after 65 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 4 generations back to K912544 (1991). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123102: Sovereign Mini, Aesculap, Inc. (2013) Summary page 5.

## Most influential descendants
- K153063: Percuvance  Percutaneous Surgical System (2016), 1 descendant of its own
- K181852: Percuvance Percutaneous Surgical System (2018), 0 descendants of its own

## Recalls of this device
- Sep 9, 2016 · Class II · Z-0058-2017: The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.
- Sep 9, 2016 · Class II · Z-0059-2017: The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.

## Indications for use
The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.

Source page: https://510kreport.com/device/K143299
Methodology: https://510kreport.com/methodology