FDA 510(k)

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525

Numéro K : K201897 · 2021-01-15

DemandeurRichard Wolf Medical Instruments Corporation

Date de décision2021-01-15

Code produitFGB

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201897. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525?

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K201897.

When did Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 receive FDA 510(k) clearance?

Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201897.

Who is the listed applicant for Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525?

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

What is the FDA product code for Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525?

The FDA product code for Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 is FGB.

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Source officielle

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