# K070165: Enseal PTC Trio

- Pathway: 510(k) (Special)
- Applicant: Surgrx, Inc.
- Decided: Jan 29, 2007 after 11 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932293 (1994). 12 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050671: Enseal Vessel Sealing & Hemostasis System, Surgrx, Inc. (2005) Summary page 1.
- K061526: Enseal PTC Tissue Sealing Device, Surgrx, Inc. (2006) Summary page 1.
- K062949: Enseal PTC Tissue Seating Sealing Device, Surgrx, Inc. (2006) Summary page 1.
- K063097: Enseal PTC Tissue Sealing Device, Surgrx, Inc. (2006) Summary page 1.

## Most influential descendants
- K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal (2008), 24 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K101990: Ethicon Endo-Surgery Generator G11, Model GEN11 (2011), 11 descendants of its own
- K141122: Harmonic Scallop Blade, Generator G11 (2014), 9 descendants of its own
- K132703: Thunderbeat (2014), 9 descendants of its own

## Recalls of this device
- Jul 9, 2010 · Not classified · Z-2635-2010: The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy

## Indications for use
The EnSeaI T M PTC TRIO of the EnSeaITM Vessel Sealing and Hemostasis system is a bipolar electrosurgical instrument for use with a radiofrequency 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, cholecystectornies, gall bladder piocedures, 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/K070165
Methodology: https://510kreport.com/methodology