FDA 510(k)

SITZMARKS

K-Number: K181750 · 2018-11-15

Decision Date2018-11-15

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SITZMARKS is the device name listed in this FDA 510(k) record. The listed applicant is Konsyl Pharmaceuticals. It received FDA 510(k) clearance on 2018-11-15 under 510(k) 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. The listed applicant is Konsyl Pharmaceuticals. The 510(k) number is K181750.

When did SITZMARKS receive FDA 510(k) clearance?

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

Who is the listed applicant for SITZMARKS?

The FDA 510(k) record lists Konsyl Pharmaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SITZMARKS?

The FDA product code for SITZMARKS is FFX.

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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.