Allura Vaginal Stent— 510(k) K202542

Substantially Equivalent

Pmt Corporation

FDA 510(k) clearance K202542 for Allura Vaginal Stent, Substantially Equivalent on 2020-09-30. Applicant: Pmt Corporation. Device class: 2.

Clearance details

Applicant: Pmt Corporation
Product code: Code KXP
Device class: Class 2
Regulation: 21 CFR 884.3900
Advisory panel: Obstetrics/Gynecology
Date received: 2020-09-02
Decision date: 2020-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXP

K983045 — AMIELLE1998-11-25
K974479 — SILIMED VAGINAL STENT1998-08-05
K920633 — PESSARY FLEXIBLE SILICONE NICHOLS1995-11-08

More clearances from Pmt Corporation

K151790 — PMT Platinum Depthalon Depth Electrode2016-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.