Avicenna Roboflex
K-Number: K233700 · 2024-08-16
Decision Date2024-08-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Avicenna Roboflex is a medical device manufactured by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2024-08-16 under approval number K233700. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avicenna Roboflex?
Avicenna Roboflex is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K233700.
When was Avicenna Roboflex approved by the FDA?
Avicenna Roboflex received FDA 510(k) clearance on 2024-08-16, under approval number K233700.
What company makes Avicenna Roboflex?
Avicenna Roboflex is manufactured by Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi.
What is the FDA product code for Avicenna Roboflex?
The FDA product code for Avicenna Roboflex is FGB.
Related Devices (Code: FGB)
K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.
K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.
K181977WiScope Digital Endoscope SystemOTU Medical, Inc.
K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.
K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp.
K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.