SOFTXIL
K-Number: K171851 · 2018-03-16
ApplicantBistool
Decision Date2018-03-16
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
SOFTXIL is the device name listed in this FDA 510(k) record. The listed applicant is Bistool. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K171851. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SOFTXIL?
SOFTXIL is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Bistool. The 510(k) number is K171851.
When did SOFTXIL receive FDA 510(k) clearance?
SOFTXIL received FDA 510(k) clearance on 2018-03-16, under 510(k) number K171851.
Who is the listed applicant for SOFTXIL?
The FDA 510(k) record lists Bistool as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SOFTXIL?
The FDA product code for SOFTXIL is MIB.
Related Devices (Code: MIB)
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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.