XR-MX/1000
K-Number: K200965 · 2020-12-29
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2020-12-29
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
XR-MX/1000 is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2020-12-29 under approval number K200965. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the XR-MX/1000?
XR-MX/1000 is a medical device that received FDA 510(k) clearance on 2020-12-29. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K200965.
When was XR-MX/1000 approved by the FDA?
XR-MX/1000 received FDA 510(k) clearance on 2020-12-29, under approval number K200965.
What company makes XR-MX/1000?
XR-MX/1000 is manufactured by Karl Storz Endoscopy America, Inc..
What is the FDA product code for XR-MX/1000?
The FDA product code for XR-MX/1000 is JAA.
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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.