# K202938: Aesculap Caiman 5 Seal and Cut Technology System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Oct 30, 2020 after 30 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: 9 generations back to K932293 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151696: Caiman Seal and Cut Technology, Aesculap, Inc. (2015) Summary page 4.

## Indications for use
Caiman Seal and Cut Technology System 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 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 Caiman 12 Plus (44cm) and the Caiman 5 (36cm and 44cm) are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) and the Caiman 5 (24cm) are 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 fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy 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 wi 11 fit in the jaws of the instrument. Caiman Seal and Cut Technology System 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/K202938
Methodology: https://510kreport.com/methodology