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FDA 510(k)

OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS

K-Number: K080187 · 2008-05-09

ApplicantOlsen Medical
Decision Date2008-05-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING 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 2008-05-09 under 510(k) number K080187. 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 OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS?

OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Olsen Medical. The 510(k) number is K080187.

When did OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS receive FDA 510(k) clearance?

OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS received FDA 510(k) clearance on 2008-05-09, under 510(k) number K080187.

Who is the listed applicant for OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING 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 OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS?

The FDA product code for OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS is GEI.

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Other records listing Olsen Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSK111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOPK072937OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SETK042073OLSEN 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.

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