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510(k) K233361

Sunny Cup and Applicator by Menstrual Mates — Product Code HHE

K233361 is an FDA 510(k) premarket notification submitted by Menstrual Mates for the device "Sunny Cup and Applicator". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code HHE (Cup, Menstrual), a Class II device regulated under 21 CFR 884.5400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Menstrual
Device Class
Class II
Regulation Number
884.5400
Review Panel
OB
Submission Type

A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Other clearances for product code HHE

  • K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUP (July 10, 2014)
  • K121857 — FEMMYCYCLE (November 15, 2012)
  • K120107 — SCKOONCUP (September 18, 2012)
  • K112165 — RHEA CUP (May 24, 2012)
  • K092985 — BELLECUP (June 28, 2010)
  • K091754 — LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (November 13, 2009)
  • K070965 — ALICIA MENSTRUAL CUP (March 5, 2008)
  • K060852 — MOONCUP (December 26, 2006)
  • K040335 — MOONCUP, STYLE A & B (March 30, 2005)
  • K021356 — THE DIVACUP MENSTRUAL SOLUTION (July 16, 2002)

FDA data resources