Home / 510(k) Clearances / K003380

510(k) K003380

BIOTEQUE VAGINAL DILATOR by Bioteque America, Inc. — Product Code HDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2001
Date Received
October 31, 2000
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 Bioteque America, Inc.

  • K041094 — HSG CATHETER SET (June 17, 2004)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K013289 — BIOTEQUE VAGINAL PESSARIES (December 27, 2001)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)
  • K920747 — PESSARY FLEXIBLE SILICONE DONUT RING (August 29, 1994)
  • K933628 — CYTOLOGY BRUSH (March 11, 1994)
  • K933521 — SPECULUM (March 7, 1994)
  • K920187 — FLEXIBLE SILICONE GELIHORN (October 23, 1992)
  • K920177 — VERSA-VIAL (July 13, 1992)

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)
  • K130273 — PANPAC VAGINAL DILATORS (August 8, 2013)
  • K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES (January 7, 2009)