# K120403: Spider Flexible Blunt Dissector and Band Passer

- Pathway: 510(k) (Traditional)
- Applicant: Transenterix, Inc.
- Decided: Apr 16, 2012 after 67 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: 7 generations back to K932648 (1993). 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)
- K100109: Logiflex Laparoscopic Band Positioning Device, Surgical Innovations Plc (2010) Summary page 1.
- K091697: Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015, Transenterix, Inc. (2009) Summary page 1.
- (no number) Realize Blunt Dissector (previously known as the Obtech Medical Goldfinger Blunt Dissector): named in the summary without a submission number

## Indications for use
The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.

Source page: https://510kreport.com/device/K120403
Methodology: https://510kreport.com/methodology