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Data / Medical devices / Stent, Vaginal

Stent, Vaginal (KXP): 3 FDA-registered makers in 2 countries

3 establishments in 2 countries are registered with the FDA to make Stent, Vaginal (product code KXP, Class 2, 21 CFR 884.3900). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on September 30, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KXP
Device class
2
Regulation
884.3900
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United Kingdom2
United States1

Makers of Stent, Vaginal

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Owen Mumford, Ltd.Woodstock, Oxfordshire, United KingdomManufacturer1November 25, 1998000api.fda.gov
Owen Mumford LimitedChipping Norton Oxfordshire, United KingdomComplaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler1November 25, 1998000api.fda.gov
PMT Corp.Chanhassen, MN, United StatesManufacturer1September 30, 2020000api.fda.gov

Updated September 30, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.