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Marina Medical Silicone Pessary

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031463

by Marina Medical Instruments, Inc.

Identifiers

510(k) Number
K031463 FDA 510(k)
FDA Product Code
HHW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.3575 FDA 510(k)
Regulation Number
884.3575 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Marina Medical Silicone Pessary is a removable vaginal pessary designed to provide mechanical support to pelvic organs. Classified as a vaginal pessary, it is intended for use in managing conditions such as uterine prolapse, retroposition, gynecologic hernia, cystocele, rectocele, and stress urinary incontinence by applying gentle pressure to the urethra and surrounding structures. Constructed from silicone, it is inserted into the vagina to restore pelvic organ alignment and improve continence.

This device is supplied as a single-use or reusable medical instrument, depending on the specific model and registration number, and is intended for use in obstetrics and gynecology settings. It is regulated under FDA 510(k) clearance (K031463) and falls under device class II (HHW). The pessary is available in multiple sizes and configurations, as indicated by the registration numbers (e.g., 3015417614, 1000221492). Storage and handling instructions are not specified in the data but should follow standard medical device protocols for silicone-based vaginal devices.

Frequently asked questions

What conditions is the Marina Medical Silicone Pessary designed to treat?

The Marina Medical Silicone Pessary is intended for managing pelvic organ prolapse, including uterine prolapse, retroposition, gynecologic hernia, cystocele, rectocele, and stress urinary incontinence. It works by applying gentle pressure to the urethra and surrounding structures to restore pelvic organ alignment and improve continence.

Is the Marina Medical Silicone Pessary single-use or reusable?

The Marina Medical Silicone Pessary is available in both single-use and reusable models, depending on the specific registration number. For example, registration numbers like 3015417614 and 1000221492 correspond to different configurations, so it’s important to verify the intended use and manufacturer guidelines for each model.

What sizes or configurations are available for the Marina Medical Silicone Pessary?

The Marina Medical Silicone Pessary comes in multiple sizes and configurations, each identified by unique registration numbers such as 3015417614, 1000221492, or others listed in the FDA database. These variations allow for customization to fit individual patient anatomy and clinical needs.

How should the Marina Medical Silicone Pessary be stored?

While specific storage instructions are not detailed in the provided data, standard medical device protocols for silicone-based vaginal devices should be followed. This typically includes keeping the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring it remains free from contamination.

What regulatory pathway does the Marina Medical Silicone Pessary follow?

The Marina Medical Silicone Pessary is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K031463. It is classified as a Class II device under the product code HHW (Hospital and Surgical, Vaginal Pessaries) and is intended for use in obstetrics and gynecology settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pessaries - Marina Medical Instruments, Marina Medical Instruments, AccessGUDID - DEVICE: Marina Medical (00840306833892), MARINA MEDICAL SILICONE PESSARY (K031463) — FDA 510 (k) | Innolitics, MARINA MEDICAL SILICONE PESSARY 510 (k) K031463 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Marina Medical Instruments, Inc.

Sources (1)

  • FDA 510(k) K031463 24 fields · synced Oct 1, 2026