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FDA 510(k)

SCKOONCUP

K-Number: K120107 · 2012-09-18

ApplicantSckoon, Inc.
Decision Date2012-09-18
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SCKOONCUP is the device name listed in this FDA 510(k) record. The listed applicant is Sckoon, Inc.. It received FDA 510(k) clearance on 2012-09-18 under 510(k) number K120107. The device is classified under product code HHE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCKOONCUP?

SCKOONCUP is a medical device that received FDA 510(k) clearance on 2012-09-18. The listed applicant is Sckoon, Inc.. The 510(k) number is K120107.

When did SCKOONCUP receive FDA 510(k) clearance?

SCKOONCUP received FDA 510(k) clearance on 2012-09-18, under 510(k) number K120107.

Who is the listed applicant for SCKOONCUP?

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

What is the FDA product code for SCKOONCUP?

The FDA product code for SCKOONCUP is HHE.

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Related Devices (Code: HHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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