510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120107Substantially Equivalent

Sckooncup

Sckoon, Inc., Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120107 is the FDA 510(k) clearance record for SCKOONCUP, a class II device, cleared for Sckoon, Inc. on under FDA product code HHE (Cup, Menstrual). FDA's definition for product code HHE reads: "A menstrual cup is a receptacle placed in the vagina to collect menstrual flow". FDA records list one 510(k) clearance for Sckoon, Inc. As of , FDA records show no recalls naming K120107.

Clearance record

Decision date
Received
(249 days to decision)
Product code
HHE Cup, Menstrual
Regulation
21 CFR 884.5400
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sckoon, Inc. 2301 Collins Ave., Miami Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HHE

Trailing 12 months

FDA records hold no clearances under product code HHE in the trailing twelve months.

FDA records show no clearances under product code HHE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260