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TIPI OTC

by Contipi, Ltd.

510(k) K131198

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131198 Date27 Aug 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HHW
FDA applicant
Contipi , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.3575
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TIPI OTC is a vaginal pessary designed to provide pelvic organ support. Classified as a Vaginal Pessary, it is intended for use in managing pelvic floor disorders, including stress urinary incontinence and pelvic organ prolapse, by mechanically supporting the bladder and surrounding structures.

Supplied as a single-use device, the TIPI OTC is manufactured by Contipi, Ltd. and falls under FDA product code HHW, regulated as a Class 2 medical device under the Traditional 510(k) pathway. It is cleared for obstetrics and gynecology applications and requires appropriate clinical assessment and fitting by a healthcare professional. Storage and handling follow standard sterile medical device protocols.

Other devices from Contipi, Ltd.

  • Tipi

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TIPI OTC pessary designed to treat?

    The TIPI OTC is a vaginal pessary intended to provide mechanical support for pelvic organs, specifically addressing pelvic floor disorders such as stress urinary incontinence and pelvic organ prolapse. It works by physically holding the bladder and surrounding structures in place, reducing symptoms associated with these conditions.

  • Is the TIPI OTC pessary reusable or single-use?

    The TIPI OTC is supplied as a single-use device. This design ensures sterility and hygiene for each patient, reducing the risk of cross-contamination and infection. Single-use devices are typically discarded after one use and replaced with a new one as needed.

  • How should the TIPI OTC pessary be stored?

    The TIPI OTC pessary must be stored following standard sterile medical device protocols. This typically includes keeping it in a sealed, sterile packaging until ready for use, protecting it from moisture, dust, and extreme temperatures. Proper storage ensures the device remains uncontaminated and functional until clinical use.

  • Does the TIPI OTC require professional fitting?

    Yes, the TIPI OTC pessary requires appropriate clinical assessment and fitting by a healthcare professional. Proper placement and sizing are critical for effectiveness and patient comfort. A clinician ensures the pessary is positioned correctly to support pelvic organs without causing discomfort or complications.

  • What regulatory pathway does the TIPI OTC follow?

    The TIPI OTC is regulated as a Class 2 medical device under the FDA’s Traditional 510(k) pathway. It was cleared through the Obstetrics/Gynecology advisory committee and is classified under product code HHW. This pathway ensures the device meets safety and effectiveness standards for its intended use in managing pelvic floor disorders.