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510(k) K090979

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES by Encision, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2009
Date Received
April 7, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
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.

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  • K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION I (November 9, 2012)
  • K093622 — AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 (August 20, 2010)
  • K100711 — SUCTION IRRIGATION ELECTRODES AND ADAPTERS (June 9, 2010)
  • K091074 — AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES (August 17, 2009)
  • K072789 — DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES (October 19, 2007)

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