# K093075: Aragon Surgical RF System Teleo Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Aragon Surgical, Inc.
- Decided: Jan 21, 2010 after 113 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932293 (1994). 13 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 21 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) Summary page 1.

## 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

## Recalls of this device
- Aug 7, 2019 · Class II · Z-2496-2019: possibility of the sterility batch being insufficiently sterilized
- Aug 7, 2019 · Class II · Z-2497-2019: possibility of the sterility batch being insufficiently sterilized

## Indications for use
The Aragon Surgical Telco Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic procedures where ligation and division of vessels is desired. The instrument creates 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 surgical procedures (including urologic, vascular, thoracic, and thoracoscopic), and gynecologic surgery 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 Telco 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/K093075
Methodology: https://510kreport.com/methodology