Atlas FDA

KXP

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Stent, Vaginal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.3900
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
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RecordFirmDate
Allura Vaginal Stent (K202542)Pmt Corporation2020-09-30
AMIELLE (K983045)Owen Mumford USA, Inc.1998-11-25
SILIMED VAGINAL STENT (K974479)Silimed, LLC1998-08-05
PESSARY FLEXIBLE SILICONE NICHOLS (K920633)Bioteque America, Inc.1995-11-08

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Every clearance here is in the API, with alerts when new ones post.