# K172775: MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Feb 12, 2018 after 151 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- 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 K945975 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070686: Mini Lap Instruments, Mini Lap Technologies, Inc. (2007) Summary page 11.
- K070352: Mini Lap Pediatric Instruments with Medusa Clamping System, Mini Lap Technologies, Inc. (2007) Summary page 11.
- K083754: Mini Lap Electrocautery Instruments, Mini Lap Technologies, Inc. (2009) Summary page 11.
- K113597: Mini-Lap Bipolar Electrocautery Devices, Minilap Technologies (2012) Summary page 8.

## Indications for use
MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery. The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery. The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic and endoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery. Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic, and endoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery. The male bipolar connection is located at the back of the handle and may be utilized for bipolar applications when attached to standard two plug bipolar cables and their generators (a male connection is provided as an integral part of the instrument).

Source page: https://510kreport.com/device/K172775
Methodology: https://510kreport.com/methodology