# K090306: Aragon Surgical RF System L2 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Aragon Surgical, Inc.
- Decided: Jun 18, 2009 after 132 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K932293 (1994). 12 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081312: Aragon Oneshot System, Aragon Surgical, Inc. (2008) Summary page 1.
- K010013: Ligasure Laparoscopic Sealer Divider Model LS1100, Valleylab, Inc. (2001)
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.

## Most influential descendants
- K110824: Aragon Surgical RF System - 5MM Laparoscopic Instrument (2011), 7 descendants of its own
- K093075: Aragon Surgical RF System Teleo Instrument (2010), 7 descendants of its own
- K130596: Caiman Seal and Cut Technology (2013), 6 descendants of its own
- K151696: Caiman Seal and Cut Technology (2015), 2 descendants of its own
- K140839: Caiman Seal and Cut Technology (2014), 1 descendant of its own

## Indications for use
The Aragon Surgical Laparoscopic (L2) Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. The indications for use include general laparoscopic procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resections, and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed. The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument. The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

Source page: https://510kreport.com/device/K090306
Methodology: https://510kreport.com/methodology