510(k) K080187

OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS by Olsen Medical — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 9, 2008
Date Received: January 25, 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 Olsen Medical

K130669 — SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEP (December 6, 2013)
K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTER (May 23, 2012)
K072937 — OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET (December 28, 2007)
K042073 — OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM (February 7, 2005)

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