Mti ST#1 Silicone Pessary

FDA 510(k) K020512 · Medical Technology and Innovations, Inc.

Substantially Equivalent

510(k) numberK020512

Submission

Device name
Mti ST#1 Silicone Pessary
Applicant
Medical Technology and Innovations, Inc.
Lee'S Summit, MO, US
Received
February 15, 2002
Decision date
May 16, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HHW – Pessary, Vaginal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.3575
Specialty
Obstetrics/Gynecology

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K231786Gynethotics™ PessaryHHW · Traditional Cosm Medical03/06/2024SE
K190277ProVate Vaginal SupportHHW · Traditional Contipi Medical , Ltd.07/08/2019SE
K183468Revive Reusable Bladder SupportHHW · Traditional Rinovum Subsidiary 2, LLC01/25/2019SE
K173351Panpac Flexi Shelf PessaryHHW · Abbreviated Panpac Medical Corporation10/31/2018SE

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Questions and answers

When was Mti ST#1 Silicone Pessary cleared by the FDA?

Mti ST#1 Silicone Pessary (K020512) received a 510(k) decision of Substantially Equivalent on May 16, 2002, 90 days after the submission was received.

What is the product code of K020512?

The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.