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510(k) K920187

FLEXIBLE SILICONE GELIHORN by Bioteque America, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1992
Date Received
January 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
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)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 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)
  • K920177 — VERSA-VIAL (July 13, 1992)

Other clearances for product code HHW

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  • K240798 — Cntrl+ Bladder Support Pessary (December 17, 2024)
  • K232677 — Reia pessary (May 21, 2024)
  • K232525 — Yoni.Fit Bladder Support (May 17, 2024)
  • K233548 — Uresta® (April 3, 2024)
  • K231786 — Gynethotics™ Pessary (March 6, 2024)
  • K190277 — ProVate Vaginal Support (July 8, 2019)
  • K183468 — Revive Reusable Bladder Support (January 25, 2019)
  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)