Home / 510(k) Clearances / K202962

510(k) 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 by New Deantronics Taiwan , Ltd. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by New Deantronics Taiwan , Ltd.

  • K251899 — E Blator (October 1, 2025)
  • K201221 — Electrosurgical Generator (September 28, 2020)
  • K200455 — Trigger Switch and Cord (March 31, 2020)
  • K193004 — Monopolar Cord (December 19, 2019)
  • K191064 — Argon Handset (June 12, 2019)
  • K183126 — Electrosurgical accessory (May 8, 2019)
  • K183594 — Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Lapa (February 19, 2019)
  • K180908 — Irrigation Tubing Bipolar Cord Set (May 18, 2018)
  • K170161 — New Deantronics E Green™ Electrosurgical Monopolar Pencils (March 29, 2017)
  • K153265 — New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated (January 5, 2016)

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  • K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (April 6, 2026)
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  • K260255 — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (March 27, 2026)
  • K253680 — LYNX COBLATION Laryngeal Wand (72290254) (March 25, 2026)
  • K253750 — BTL-785NEH (March 17, 2026)
  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)