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FDA 510(k)

SITZMARKS

K-Number: K181750 · 2018-11-15

ApplicantKonsyl Pharmaceuticals
Decision Date2018-11-15
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SITZMARKS is a medical device manufactured by Konsyl Pharmaceuticals. It received FDA 510(k) clearance on 2018-11-15 under approval number K181750. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SITZMARKS?

SITZMARKS is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by Konsyl Pharmaceuticals. The 510(k) number is K181750.

When was SITZMARKS approved by the FDA?

SITZMARKS received FDA 510(k) clearance on 2018-11-15, under approval number K181750.

What company makes SITZMARKS?

SITZMARKS is manufactured by Konsyl Pharmaceuticals.

What is the FDA product code for SITZMARKS?

The FDA product code for SITZMARKS is FFX.

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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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