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510(k) K920633

PESSARY FLEXIBLE SILICONE NICHOLS by Bioteque America, Inc. — Product Code KXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1995
Date Received
February 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, 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)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)
  • 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 KXP

  • K202542 — Allura Vaginal Stent (September 30, 2020)
  • K983045 — AMIELLE (November 25, 1998)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)