# K071728: Modification to: Enseal PTC Tissue Sealing Device

- Pathway: 510(k) (Special)
- Applicant: Surgrx, Inc.
- Decided: Jul 13, 2007 after 18 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). 12 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031133: Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis, Surgrx, Inc. (2003) Summary page 1.
- K060484: Erbe Vio Esu, Model Vio 300 D, Erbe USA, Inc. (2006) Summary page 1.
- K061526: Enseal PTC Tissue Sealing Device, Surgrx, Inc. (2006) Summary page 1.

## Most influential descendants
- K110639: Endowrist One Vessel Sealer (2011), 15 descendants of its own
- K130266: Endowrist One Vessel Sealer (2013), 10 descendants of its own
- K140189: Endowrist Vessel Sealer (2014), 9 descendants of its own
- K170865: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (2017), 8 descendants of its own
- K173337: Intuitive Surgical EndoWrist Vessel Sealer Extend (2018), 7 descendants of its own

## Indications for use
The EnSeal PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. 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 & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

Source page: https://510kreport.com/device/K071728
Methodology: https://510kreport.com/methodology