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510(k) K130273

PANPAC VAGINAL DILATORS by Panpac Medical Corporation — Product Code HDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2013
Date Received
February 4, 2013
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 Panpac Medical Corporation

  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)
  • K161106 — PANPAC DISPOSABLE VACUUM CURETTES (January 13, 2017)
  • K153422 — Panpac Disposable Pessary Fitting Set (July 14, 2016)
  • K132670 — PANPAC INFLATABLE DOCUT PESSARY (June 4, 2014)
  • K130087 — PANPAC WORD/BARTHOLIN CATHETER (January 10, 2014)
  • K102898 — BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY (December 15, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K092981 — PANPAC VAGINAL PESSARY (July 22, 2010)
  • K092983 — PANPAC HSG CATHETER SET (June 7, 2010)
  • K092984 — PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (April 7, 2010)

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)
  • K211959 — Milli Vaginal Dilator (December 1, 2021)
  • K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES (January 7, 2009)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)