FDA 510(k)

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps

Numéro K : K182773 · 2019-10-08

Date de décision2019-10-08

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps is the device name listed in this FDA 510(k) record. The listed applicant is Faulhaber Pinzetten Ohg. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K182773. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps?

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Faulhaber Pinzetten Ohg. The 510(k) number is K182773.

When did Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps receive FDA 510(k) clearance?

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps received FDA 510(k) clearance on 2019-10-08, under 510(k) number K182773.

Who is the listed applicant for Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps?

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

What is the FDA product code for Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps?

The FDA product code for Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps is GEI.

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Source officielle

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