510(k) K040855

INSTRUMED LAPAROSCOPE AND ACCESSORIES by Instrumed International, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 16, 2004
Date Received: April 2, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

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 Instrumed International, Inc.

K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (April 29, 2010)
K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
K092544 — INSTRUMED VASCULAR CLAMPS (October 26, 2009)
K081651 — INSTRUMED RONGEUR (August 8, 2008)
K071771 — INSTRUMED RETRACTORS (August 2, 2007)

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