BESPA Charcot System
K-Number: K202326 · 2021-11-09
ApplicantBespa Global, LLC
Decision Date2021-11-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BESPA Charcot System is a medical device manufactured by Bespa Global, LLC. It received FDA 510(k) clearance on 2021-11-09 under approval number K202326. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BESPA Charcot System?
BESPA Charcot System is a medical device that received FDA 510(k) clearance on 2021-11-09. It is manufactured by Bespa Global, LLC. The 510(k) number is K202326.
When was BESPA Charcot System approved by the FDA?
BESPA Charcot System received FDA 510(k) clearance on 2021-11-09, under approval number K202326.
What company makes BESPA Charcot System?
BESPA Charcot System is manufactured by Bespa Global, LLC.
What is the FDA product code for BESPA Charcot System?
The FDA product code for BESPA Charcot System is HWC. This falls under the Cardiovascular category.
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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.