Home / 510(k) Clearances / K152031

510(k) K152031

New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter. by New Deantronics Taiwan , Ltd. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2015
Date Received
July 22, 2015
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)
  • K202962 — Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Butt (November 20, 2020)
  • 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)

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