510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202542Substantially Equivalent

Allura Vaginal Stent

PMT Corp., Chanhassen MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K202542 is the FDA 510(k) clearance record for Allura Vaginal Stent, a class II device, cleared for Pmt Corporation on under FDA product code KXP (Stent, Vaginal). FDA records list 22 510(k) clearances for Pmt Corporation, from to . As of , FDA records show no recalls naming K202542.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KXP Stent, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pmt Corporation 1500 Park Rd., Chanhassen MN
510(k) summary
Statement
Third party review
Yes

Clearances, product code KXP

Trailing 12 months

FDA records hold no clearances under product code KXP in the trailing twelve months.

FDA records show no clearances under product code KXP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260