Home / 510(k) Clearances / K093622

510(k) K093622

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 by Encision, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2010
Date Received
November 23, 2009
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 Encision, Inc.

  • K201018 — Encision AEM enTouch 2X Scissor (July 15, 2020)
  • K140006 — ENDOSHIELD BURN PROTECTION SYSTEM (June 16, 2014)
  • K131949 — AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES (August 26, 2013)
  • K122383 — EM3 AEM MONITOR AEM CONNECTORS (January 10, 2013)
  • K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION I (November 9, 2012)
  • K100711 — SUCTION IRRIGATION ELECTRODES AND ADAPTERS (June 9, 2010)
  • K091074 — AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES (August 17, 2009)
  • K090979 — DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES (May 28, 2009)
  • K072789 — DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES (October 19, 2007)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)