# K140839: Caiman Seal and Cut Technology

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Apr 28, 2014 after 26 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: 8 generations back to K932293 (1994). 19 ancestors in all.
1 later device descends 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)
- K130596: Caiman Seal and Cut Technology, Aesculap, Inc. (2013) Summary page 1.

## Most influential descendants
- K151858: Caiman Seal and Cut Technology (2015), 0 descendants of its own

## Indications for use
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar clectrosurgicall RE energy (coagulation) to vascular structure (vessels) interposed between thejaws of te device. A cutting blade is actuated for the division of tissue. The Caimnan 12 Plus (44cm) and the Caiman 5 are indicated for laparoscopic procedures and the Cainman 12 Plus (24cm) is indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fuandoplication, colectomy, adhesiolysis, bowel resection, and oophorectomny etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument. Caiman Seal and Cut Technology 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/K140839
Methodology: https://510kreport.com/methodology