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FDA 510(k)

SOFTXIL

K-Number: K171851 · 2018-03-16

ApplicantBistool
Decision Date2018-03-16
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SOFTXIL is a medical device manufactured by Bistool. It received FDA 510(k) clearance on 2018-03-16 under approval 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. It is manufactured by Bistool. The 510(k) number is K171851.

When was SOFTXIL approved by the FDA?

SOFTXIL received FDA 510(k) clearance on 2018-03-16, under approval number K171851.

What company makes SOFTXIL?

SOFTXIL is manufactured by Bistool.

What is the FDA product code for SOFTXIL?

The FDA product code for SOFTXIL is 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.

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