510(k) K081553

AED BIPOLAR FORCEPS, MODEL 13-1646 by National Advanced Endoscopy Devices, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 29, 2008
Date Received: June 3, 2008
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 National Advanced Endoscopy Devices, Inc.

K170285 — AED Sinuscope (August 1, 2017)
K141515 — AED HYSTEROSCOPE AND ACCESSORIES (January 7, 2015)
K102663 — AED RESECTOSCOPE (December 30, 2010)
K081503 — AED MONOPOLAR LAP ACCESSORIES (September 25, 2008)
K993689 — AED CYSTOSCOPE (December 15, 1999)
K993688 — AED LAPAROSCOPE (December 6, 1999)
K991656 — AED ARTHROSCOPE (December 2, 1999)

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