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Panpac Inflatable Docut Pessary

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132670

by Panpac Medical Corporation

Identifiers

510(k) Number
K132670 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)

This device is a vaginal pessary, specifically an inflatable pessary, used in the field of obstetrics and gynecology. It is designed to provide support for pelvic organ prolapse or urinary incontinence by being inserted into the vagina and inflated to conform to the patient's anatomy.

The device is supplied non-sterile and is intended for reusable use after proper cleaning and disinfection between patients. It is regulated as a Class II medical device under FDA 510(k) clearance K132670, with product code HHW and regulation number 884.3575, and was determined to be substantially equivalent to a legally marketed predicate device.

Frequently asked questions

Is this pessary designed for single-use or reusable applications, and what cleaning instructions are required if it is reusable?

The PANPAC Inflatable Docut Pessary is intended for reusable use after proper cleaning and disinfection between patients. Since it is supplied non-sterile, it must be thoroughly cleaned and disinfected to maintain safety and hygiene before each use. The manufacturer’s instructions (not provided in the data) would outline the specific cleaning and disinfection protocols, but reusable devices in this category typically require sterilization or high-level disinfection to prevent cross-contamination.

What sizes or models of the PANPAC Inflatable Docut Pessary are available, and how does a clinician determine the correct fit for a patient?

The data does not specify exact sizes or model variations, but the PANPAC Inflatable Docut Pessary is designed to conform to the patient’s anatomy through inflation, suggesting it may offer adjustable sizing. Clinicians would typically measure the patient’s vaginal canal and pelvic anatomy to select the appropriate model or size, following standard pessary-fitting protocols. The inflatable feature allows for customization post-insertion, but precise sizing guidance would rely on the manufacturer’s sizing charts or clinical expertise.

How should the PANPAC Inflatable Docut Pessary be stored, and are there any special handling requirements before use?

Since the device is non-sterile and reusable, it should be stored in a clean, dry environment to prevent contamination between uses. Before insertion, it must be thoroughly cleaned and disinfected as per the manufacturer’s instructions. The packaging (not detailed here) likely includes storage guidelines, but general practice for reusable pessaries involves avoiding moisture exposure and ensuring the device remains intact until ready for reprocessing.

What regulatory pathway was followed for FDA clearance of this device, and how does that affect its clinical use?

The PANPAC Inflatable Docut Pessary received FDA 510(k) clearance (K132670) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a legally marketed predicate device. This means the device was determined to have the same intended purpose and technological characteristics as an existing approved pessary, ensuring it meets FDA safety and effectiveness standards for obstetrics/gynecology use. Clinically, this clearance confirms the device’s compliance with U.S. regulations for pelvic organ prolapse or urinary incontinence support.

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: PANPAC INFLATABLE DOCUT PESSARY (K132670) — FDA 510 (k) | Innolitics, Panpac Inflatable Docut Pessary - Beudamed, PANPAC INFLATABLE DOCUT PESSARY 510 (k) K132670 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Panpac Medical Corporation

Sources (1)

  • FDA 510(k) K132670 24 fields · synced Sep 19, 2026