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510(k) K121857

FEMMYCYCLE by Femcap Incorporated — Product Code HHE

K121857 is an FDA 510(k) premarket notification submitted by Femcap Incorporated for the device "FEMMYCYCLE". The FDA issued a decision of Substantially Equivalent on November 15, 2012. 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
November 15, 2012
Date Received
June 26, 2012
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

  • K233361 — Sunny Cup and Applicator (June 21, 2024)
  • K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUP (July 10, 2014)
  • 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