# K100109: Logiflex Laparoscopic Band Positioning Device

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Innovations Plc
- Decided: Jul 15, 2010 after 182 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: 6 generations back to K932648 (1993). 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)
- K063485: Logic Laparoscopic Scissors, Surgical Innovations Plc (2006) Summary page 1.
- K991928: Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors, Allegiance Healthcare Corp. (1999) Summary page 1.
- (no number) Goldfinger Blunt Dissector: named in the summary without a submission number

## Most influential descendants
- K120403: Spider Flexible Blunt Dissector and Band Passer (2012), 0 descendants of its own

## Indications for use
Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.

Source page: https://510kreport.com/device/K100109
Methodology: https://510kreport.com/methodology