Cleared Traditional

K202962 - Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft (FDA 510(k) Clearance)

K202962 · New Deantronics Taiwan , Ltd. · General & Plastic Surgery device

Nov 2020

Decision

51d

Days

Class 2

Risk

K202962 is an FDA 510(k) clearance for the Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II - Special Controls, product code GEI).

Submitted by New Deantronics Taiwan , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on November 20, 2020, 51 days after receiving the submission on September 30, 2020.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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)..

Submission Details

510(k) Number	K202962 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2020
Decision Date	November 20, 2020
Days to Decision	51 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI - Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 878.4400
Definition	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).