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510(k) K112165

RHEA CUP by Apex Medical Technologies, Inc. — Product Code HHE

K112165 is an FDA 510(k) premarket notification submitted by Apex Medical Technologies, Inc. for the device "RHEA CUP". The FDA issued a decision of Substantially Equivalent on May 24, 2012. The device falls under product code HHE (Cup, Menstrual), a Class II device regulated under 21 CFR 884.5400. Apex Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2012
Date Received
July 28, 2011
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 by Apex Medical Technologies, Inc.

  • K060933 — SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM (May 9, 2006)
  • K954791 — SEMINAL FLUID COLLECTION KIT II (January 5, 1996)
  • K922688 — EXTRA PROTECTION POLYURETHANE CONDOM (May 4, 1995)
  • K930313 — APEX SPECIMEN BAG (March 18, 1993)
  • K902936 — POLYURETHANE CONDOM (March 6, 1991)
  • K871358 — SENSATIONS BRAND CONDOMS (March 1, 1989)
  • K874539 — HI-TOUCH (TM) BRAND SURGICAL GLOVES (December 14, 1987)

Other clearances for product code HHE

  • K233361 — Sunny Cup and Applicator (June 21, 2024)
  • K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUP (July 10, 2014)
  • K121857 — FEMMYCYCLE (November 15, 2012)
  • K120107 — SCKOONCUP (September 18, 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