# K031133: Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis

- Pathway: 510(k) (Traditional)
- Applicant: Surgrx, Inc.
- Decided: Jul 3, 2003 after 85 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: 2 generations back to K932293 (1994). 7 ancestors in all.
56 later devices descend from it; 6 cite it directly.
0 of 64 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.

## Most influential descendants
- K061526: Enseal PTC Tissue Sealing Device (2006), 53 descendants of its own
- K063097: Enseal PTC Tissue Sealing Device (2006), 34 descendants of its own
- K070896: Enseal PTC Tissue Sealing Device (2007), 32 descendants of its own
- K062949: Enseal PTC Tissue Seating Sealing Device (2006), 26 descendants of its own
- K050671: Enseal Vessel Sealing & Hemostasis System (2005), 26 descendants of its own

## Indications for use
The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It Is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the Instruments. The SurgRx EnSeal Vessel Sealing & Hemoslasis System has not been shown effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

Source page: https://510kreport.com/device/K031133
Methodology: https://510kreport.com/methodology