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FDA 510(k), K192245, Pentax Medical Video Duodenoscope ED34-i10T2
FDA 510(k), K192245, Pentax Medical Video Duodenoscope ED34-i10T2
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510(K) Number: K192245
Device Name: Pentax Medical Video Duodenoscope ED34-i10T2
Manufacturer: William Goeller
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: KXA
Date Received: 08/19/2019
Decision Date: 11/15/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Pentax Medical Video Duodenoscope ED34-i10T2
Manufacturer: William Goeller
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: KXA
Date Received: 08/19/2019
Decision Date: 11/15/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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