FDA 510(k)

True Tulip, True M.I.S.

K-Number: K210816 · 2021-05-18

ApplicantInnovative Surgical Designs, Inc.

Decision Date2021-05-18

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

True Tulip, True M.I.S. is a medical device manufactured by Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2021-05-18 under approval number K210816. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the True Tulip, True M.I.S.?

True Tulip, True M.I.S. is a medical device that received FDA 510(k) clearance on 2021-05-18. It is manufactured by Innovative Surgical Designs, Inc.. The 510(k) number is K210816.

When was True Tulip, True M.I.S. approved by the FDA?

True Tulip, True M.I.S. received FDA 510(k) clearance on 2021-05-18, under approval number K210816.

What company makes True Tulip, True M.I.S.?

True Tulip, True M.I.S. is manufactured by Innovative Surgical Designs, Inc..

What is the FDA product code for True Tulip, True M.I.S.?

The FDA product code for True Tulip, True M.I.S. is NKB.

Other Devices by Innovative Surgical Designs, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.