EasyInstruments

Q: When was EasyInstruments cleared by the FDA?

EasyInstruments (K182013) received a 510(k) decision of Substantially Equivalent on March 11, 2019, 227 days after the submission was received.

Q: What is the product code of K182013?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K182013 · Agency For Medical Innovations GmbH

Substantially Equivalent

510(k) numberK182013

Submission

Device name: EasyInstruments
Applicant: Agency For Medical Innovations GmbH
Feldkirch, AT
Received: July 27, 2018
Decision date: March 11, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was EasyInstruments cleared by the FDA?

EasyInstruments (K182013) received a 510(k) decision of Substantially Equivalent on March 11, 2019, 227 days after the submission was received.

What is the product code of K182013?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.