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K Number
K173351
Device Name
Panpac Flexi Shelf Pessary
Manufacturer
Panpac Medical Corporation
Date Cleared
2018-10-31

(371 days)

Product Code
HHW
Regulation Number
884.3575
Type
Abbreviated
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Flexi Shelf Pessary is indicated for use as a removable structure placed in the support of a second to third degree prolapse or procidentia.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Panpac Flexi Shelf Pessary, which concerns the regulatory approval of a medical device based on its substantial equivalence to a predicate device, not on specific performance acceptance criteria and associated studies.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study findings based on the provided text.

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).