Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910

Q: What is the product code of K061417?

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) K061417 · Genicon

Substantially Equivalent

510(k) numberK061417

Submission

Device name: Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910
Applicant: Genicon
Winter Park, FL, US
Received: May 22, 2006
Decision date: October 10, 2006
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 Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 cleared by the FDA?

Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 (K061417) received a 510(k) decision of Substantially Equivalent on October 10, 2006, 141 days after the submission was received.

What is the product code of K061417?

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