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510(k) K920792

SOFTCUP(TM):2 by Ultrafem, Inc. — Product Code HHE

K920792 is an FDA 510(k) premarket notification submitted by Ultrafem, Inc. for the device "SOFTCUP(TM):2". The FDA issued a decision of Substantially Equivalent on October 5, 1993. The device falls under product code HHE (Cup, Menstrual), a Class II device regulated under 21 CFR 884.5400. Ultrafem, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1993
Date Received
February 21, 1992
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 Ultrafem, Inc.

  • K971303 — INSTEAD, SOFTCUP (June 6, 1997)

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)
  • 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)

FDA data resources