# K062949: Enseal PTC Tissue Seating Sealing Device

- Pathway: 510(k) (Special)
- Applicant: Surgrx, Inc.
- Decided: Oct 18, 2006 after 19 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). 9 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061526: Enseal PTC Tissue Sealing Device, Surgrx, Inc. (2006) Summary page 1.

## Most influential descendants
- K070165: Enseal PTC Trio (2007), 25 descendants of its own
- 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

## Indications for use
The SurgRx EnSeal system includes bipolar electrosurgical instruments and 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, 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/K062949
Methodology: https://510kreport.com/methodology