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510(k) K202542

Allura Vaginal Stent by Pmt Corporation — Product Code KXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2020
Date Received
September 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stent, Vaginal
Device Class
Class II
Regulation Number
884.3900
Review Panel
OB
Submission Type

Other clearances by Pmt Corporation

  • K151790 — PMT Platinum Depthalon Depth Electrode (July 14, 2016)

Other clearances for product code KXP

  • K983045 — AMIELLE (November 25, 1998)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)