510(k) K955834

SYSTEM 6500 ABC ELECTROSURGICAL UNIT by Aspen Laboratories, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 11, 1996
Date Received: December 26, 1995
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 Aspen Laboratories, Inc.

K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
K960296 — 4000 ETM (February 20, 1996)
K953081 — BEAMER PLUS (October 30, 1995)
K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)
K896838 — BISTAT ELECTROSURGICAL UNIT 60-5400-001 (February 13, 1990)

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