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510(k) K211959

Milli Vaginal Dilator by Materna Medical — Product Code HDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2021
Date Received
June 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Materna Medical

  • K220035 — Milli Vaginal Dilator (February 27, 2023)

Other clearances for product code HDX

  • K241748 — Intimate Rose Vaginal Dilators (August 14, 2024)
  • 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)
  • K130273 — PANPAC VAGINAL DILATORS (August 8, 2013)
  • K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES (January 7, 2009)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)