FDA 510(k)

SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS

K-Number: K130669 · 2013-12-06

Decision Date2013-12-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Medical. It received FDA 510(k) clearance on 2013-12-06 under 510(k) number K130669. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS?

SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS is a medical device that received FDA 510(k) clearance on 2013-12-06. The listed applicant is Olsen Medical. The 510(k) number is K130669.

When did SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS receive FDA 510(k) clearance?

SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS received FDA 510(k) clearance on 2013-12-06, under 510(k) number K130669.

Who is the listed applicant for SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS?

The FDA 510(k) record lists Olsen Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS?

The FDA product code for SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS is GEI.

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Other records listing Olsen Medical as applicant

K111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP K080187OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS K072937OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET K042073OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.