# K081312: Aragon Oneshot System

- Pathway: 510(k) (Traditional)
- Applicant: Aragon Surgical, Inc.
- Decided: Oct 31, 2008 after 175 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: 4 generations back to K932293 (1994). 11 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.
- K041587: Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500, Valleylab (2004) Summary page 1.

## Most influential descendants
- K090306: Aragon Surgical RF System L2 Instrument (2009), 9 descendants of its own
- 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

## Indications for use
The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

Source page: https://510kreport.com/device/K081312
Methodology: https://510kreport.com/methodology