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510(k) K974479

SILIMED VAGINAL STENT by Silimed, LLC — Product Code KXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1998
Date Received
November 26, 1997
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 Silimed, LLC

  • K042054 — SILIMED PECTORAL IMPLANT (February 23, 2005)
  • K981852 — SILIMED TISSUE EXPANDER (August 5, 1998)
  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)
  • K980221 — SILIMED NASAL RETAINER (April 2, 1998)
  • K974482 — SILIMED GLUTEAL IMPLANT (February 24, 1998)
  • K974480 — SILIMED CALF IMPLANT (February 24, 1998)

Other clearances for product code KXP

  • K202542 — Allura Vaginal Stent (September 30, 2020)
  • K983045 — AMIELLE (November 25, 1998)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)