# K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal

- Pathway: 510(k) (Traditional)
- Applicant: Surgrx, Inc.
- Decided: Jul 28, 2008 after 98 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: 6 generations back to K932293 (1994). 26 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 51 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.
- K043008: Surgrx Enseal Vessel Sealing & Hemostasis System, Surgrx, Inc. (2004) Summary page 1.
- 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.
- K070165: Enseal PTC Trio, Surgrx, Inc. (2007) Summary page 1.
- K070896: Enseal PTC Tissue Sealing Device, Surgrx, Inc. (2007) Summary page 1.
- K072177: Enseal Vessel Sealing and Hemostasis System, Surgrx, Inc. (2007) Summary page 1.
- K072493: Enseal Tissue Sealing Device, Surgrx, Inc. (2007) Summary page 1.
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044, Valleylab (2006) Summary page 1.
- K031079: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode, Gyrus Medical, Inc. (2003) Summary page 1.
- K051644: Valleylab Forcetriad Electrosurgical Generator, Valleylab (2005) Summary page 1.

## Most influential descendants
- 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
- K160554: Enseal X1 Large Jaw Tissue Sealer (2016), 6 descendants of its own

## Indications for use
The EnSeal PowerTip is an electrosurgical instrument for use with the EnSeal Universal 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), 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 cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies. The EnSeal PowerTip 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/K081129
Methodology: https://510kreport.com/methodology