# K110824: Aragon Surgical RF System - 5MM Laparoscopic Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Aragon Surgical, Inc.
- Decided: Jul 11, 2011 after 110 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: 6 generations back to K932293 (1994). 16 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090306: Aragon Surgical RF System L2 Instrument, Aragon Surgical, Inc. (2009)
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500, Valleylab, Inc. (2003) Summary page 1.
- K092879: Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider, Valleylab (2009) Summary page 1.
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments, Valleylab,A Division of Tyco Healthcare Group LP (2007). Our reading of the summary gave K070612, FDA’s number for Top-Rank Adhesive Electrode (Top-Rank Health Care Equipment Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Valleylab ForceTriad RF Generator”.

## Most influential descendants
- 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
- K203461: Aesculap Caiman 12 Seal and Cut Technology System (2020), 0 descendants of its own
- K202938: Aesculap Caiman 5 Seal and Cut Technology System (2020), 0 descendants of its own

## Indications for use
The Aragon Surgical Caiman 5 Laparoscopic 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 instrument creates a seal by the application of bipolar electrosurgical RF energy to vascular structures (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. Indications for use include general laparoscopic procedures, including urologic, vascular, thoracic, and thoracsocopic, and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy etc. The Aragon Surgical Caiman 5 Laparoscopic Instrument can be used on vessels up to and including 7mm, and tissue bundles as large as will fit in the jaws of the instrument. The Aragon Surgical Lektrafuse RF System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Source page: https://510kreport.com/device/K110824
Methodology: https://510kreport.com/methodology