# K153063: Percuvance  Percutaneous Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Apr 8, 2016 after 169 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K912544 (1991). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143299: Percuvance (R) Percutaneous Surgical System, Teleflexmedical, Inc. (2015) Summary page 5.
- K083754: Mini Lap Electrocautery Instruments, Mini Lap Technologies, Inc. (2009) Summary page 7.

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

## Recalls of this device
- Jan 3, 2018 · Class II · Z-0753-2019: There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and securi
- Jan 3, 2018 · Class II · Z-0754-2019: There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and securi
- Oct 18, 2017 · Class II · Z-0059-2018: Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.
- Jul 19, 2017 · Class II · Z-3222-2017: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may 
- Jul 19, 2017 · Class II · Z-3220-2017: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may 
- Jul 19, 2017 · Class II · Z-3223-2017: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may 
- Jul 19, 2017 · Class II · Z-3224-2017: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may 
- Jul 19, 2017 · Class II · Z-3221-2017: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may 
- Jul 19, 2017 · Class II · Z-3219-2017: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may 

## Indications for use
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Source page: https://510kreport.com/device/K153063
Methodology: https://510kreport.com/methodology