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510(k) K241748

Intimate Rose Vaginal Dilators by Plus EV Holdings Dba Intimate Rose — Product Code HDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2024
Date Received
June 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Dilator, Vaginal
Device Class
Class II
Regulation Number
884.3900
Review Panel
OB
Submission Type

Other clearances by Plus EV Holdings Dba Intimate Rose

  • K231430 — Intimate Rose Vaginal Dilators (June 7, 2023)
  • K193364 — Intimate Rose Kegel Exercise System (August 24, 2020)

Other clearances for product code HDX

  • K233689 — Hope&Her Vaginal Dilators (May 2, 2024)
  • K222492 — Hope&Her Vaginal Dilators (June 27, 2023)
  • K231430 — Intimate Rose Vaginal Dilators (June 7, 2023)
  • K220035 — Milli Vaginal Dilator (February 27, 2023)
  • K211959 — Milli Vaginal Dilator (December 1, 2021)
  • K130273 — PANPAC VAGINAL DILATORS (August 8, 2013)
  • K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES (January 7, 2009)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)