Enseal Vessel Sealing and Hemostasis System

• • Terminated Z-2635-2010 FDA Unclassified (pre-2012) ·initiated 9 Jul 2010 ·on shared 510(k) K072177

  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 to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K072177 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Enseal Ptc Tissue Sealing Device

  Class II

  FDA 510(k) K070896 Active Cleared 24 Apr 2007

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

  Class II

  FDA 510(k) K081129 Active Cleared 28 Jul 2008

• Enseal Tissue Sealing Device

  Class II

  FDA 510(k) K072493 Active Cleared 27 Sep 2007

• Enseal Vessel Sealing & Hemostasis System

  Class II

  FDA 510(k) K050671 Active Cleared 1 Apr 2005

• Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis

  Class II

  FDA 510(k) K031133 Active Cleared 3 Jul 2003

• Surgrx Enseal Vessel Sealing & Hemostasis System

  Class II

  FDA 510(k) K043008 Active Cleared 17 Nov 2004

See all devices from Surgrx, Inc. →

• What is the Enseal Vessel Sealing and Hemostasis System used for?

  The Enseal Vessel Sealing and Hemostasis System is designed for vessel sealing and hemostasis during surgical procedures. It uses bipolar electrosurgical technology to deliver controlled electrical energy directly to targeted tissues, ensuring precise occlusion of vessels while reducing damage to surrounding areas. This makes it suitable for both open and laparoscopic surgeries in general and gynecologic fields, where minimizing collateral tissue impact is critical.

• How is the Enseal System supplied and what does it require for operation?

  The Enseal Vessel Sealing and Hemostasis System is supplied as a reusable instrument. It must be paired with an external electrosurgical generator to function. The system itself does not include the generator, so compatibility with the generator’s specifications is essential for safe and effective use.

• Is the Enseal System intended for single-use or reusable?

  The Enseal System is intended for single-use per procedure or as directed by the manufacturer’s instructions. While the instrument itself is reusable, each use requires adherence to the manufacturer’s guidelines to ensure sterility and performance. Standard surgical precautions should be followed to maintain safety and efficacy.

• What storage guidelines apply to the Enseal Vessel Sealing System?

  The Enseal System should be stored according to general electrosurgical device guidelines. Since it is reusable, storage should protect it from contamination, physical damage, and environmental factors that could compromise its functionality. Always follow the manufacturer’s specific storage instructions to maintain device integrity and ensure readiness for use.

• Does the Enseal System have any specific sterility or MRI safety information?

  The provided data does not specify sterility requirements or MRI safety information for the Enseal System. Standard surgical precautions should be applied during use, and users should refer to the manufacturer’s instructions for any additional handling or safety guidelines. If MRI compatibility is a concern, further inquiry with Surgrx, Inc. is recommended.