Tipi OTC

FDA 510(k) K131198 · Contipi , Ltd.

Substantially Equivalent

510(k) numberK131198

Submission

Device name
Tipi OTC
Applicant
Contipi , Ltd.
Washington, DC, US
Received
April 26, 2013
Decision date
August 27, 2013
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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Questions and answers

When was Tipi OTC cleared by the FDA?

Tipi OTC (K131198) received a 510(k) decision of Substantially Equivalent on August 27, 2013, 123 days after the submission was received.

What is the product code of K131198?

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