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E Blator

New Deantronics Taiwan , Ltd.

Country / Region:Taiwan (TW)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

Taiwan (TW)

Product code

GEI
21 CFR 878.4400

Predicate devices

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251899
Device name
E Blator
Country / Region
Taiwan(TW)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2025-06-20
Decision date
2025-10-01
Submission type
Traditional
Technology type
RF Ablation(AI inferred)
Clinical applications
SurgeryTissue RepairPain Management
Primary application
Surgery
Classification source
AI classified

Indications for Use

The E Blator is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution. The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.

Intended Use

The E Blator is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

Device Description

The device is equipped with a patented stainless steel electrode tip encased in a thermal insulator. When used in combination with a compatible electrosurgical generator, the device provides radio frequency (RF) energy for cutting, vaporizing, and coagulating soft tissue. The device enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect with handswitch control, said current then returns back to the electrosurgical unit through the return electrode and connector. This provides the capability for the surgeon to balance tissue dissection and hemostatic effects as needed during a given surgical case. For aspirating models, when coupled with a vacuum system, the surgical field can be cleared of undesirable debris simultaneously by using the aspiration port located at the bottom of the face of the electrode. Removing this debris can facilitate the surgeon's visualization of the surgical field.

Summary parsed at:2026-06-20 17:49:33 UTC

Predicate devices

4

K251899 references 4 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251899 as a predicate