510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Fiagon GmbH

Hennigsdorf Brandenburg, DE

Fiagon GMBH appears in FDA device records in Hennigsdorf Brandenburg, DE. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Fiagon GmbH between 2014 and 2026. The busiest year on record is 2016, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Fiagon GmbH, by decision year
YearClearances
20142
20151
20165
20172
20202
20211
20232
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261540Cube 4D Navigation System, VirtuEye ProPGWSubstantially Equivalent
K230700RIWOtrack Navigation SystemOLOSubstantially Equivalent
K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemPNZSubstantially Equivalent
K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGWSubstantially Equivalent
K201472VenSure Balloon Device, VenSure Nav Balloon DeviceLRCSubstantially Equivalent
K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGWSubstantially Equivalent
K163209Fiagon Navigation SystemHAWSubstantially Equivalent
K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatPGWSubstantially Equivalent
K162176Fiagon Navigation SystemPGWSubstantially Equivalent
K161940Guidewire 0.6 Single UsePGWSubstantially Equivalent
K151156Fiagon Navigation SystemHAWSubstantially Equivalent
K160479PointerShell Universal, PointerShell LSPGWSubstantially Equivalent
K160369GuideWirePGWSubstantially Equivalent
K150473FlexPointer 1.5 mmPGWSubstantially Equivalent
K141456THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELLPGWSubstantially Equivalent
K133573FIAGON NAVIGATION SYSTEMPGWSubstantially Equivalent

Registered establishments

FDA registered establishments for Fiagon GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30103135883010313588Fiagon GMBHNeuendorfstr. 23b, Hennigsdorf Brandenburg 16761 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain