Devices

Device Recall Encision AEM Suction Irrigation Electrode, LHook,

Model / Serial
Catalog: REF ES3883. Lots QI, RA, and RE.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
Product Description
Encision AEM Suction Irrigation Electrode, L-Hook, || REF ES3883, || Encision Inc., || Boulder, CO 80301. || The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.
Manufacturer
Encision, Inc.
1 Event
- Recall of Device Recall Encision AEM Suction Irrigation Electrode, LHook,

Manufacturer

Encision, Inc.

Manufacturer Address
Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
Manufacturer Parent Company (2017)
Encision, Inc.
Source
USFDA

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