Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A Gellhorn pessary is a silicone support device with a concave base and a stem ending in a knob. This page is for clinic staff, supply buyers and students who need to tell Gellhorn, donut and shelf pessaries apart, and to know how the device is classified in the United States.
What is a Gellhorn pessary?
A Gellhorn pessary is one of the support-type vaginal pessaries. The US federal regulation defines a vaginal pessary as “a removable structure placed in the vagina to support the pelvic organs” (21 CFR 884.3575(a), checked 2026-10-30). A Gloucestershire Hospitals NHS Foundation Trust patient leaflet describes the Gellhorn as “a flexible silicone device to support moderate to severe prolapse of the womb or the top of the vagina (vault)” (checked 2026-10-30).
The device is fitted and followed up by a clinician, and it is handled by clinic staff, procurement teams and students of gynecology. Its use in a given patient is a clinical decision.
How is a Gellhorn pessary built?
In the Global Library of Women’s Medicine chapter on pessaries (Thakar, last updated July 2014, checked 2026-10-30), the base is circular with a concave surface on the bottom and a convex surface on top, with a stem of varying length ending in a knob. The NHS leaflet describes the material as flexible silicone.
What is the difference between Gellhorn, donut and shelf pessaries?
The table sets out how each source describes the three types. The two sources use different wording and categories, so each cell names its source.
| Type | Shape and material as described | Stated use | Source |
|---|---|---|---|
| Gellhorn | Flexible silicone. Circular base, concave underneath and convex on top, with a stem ending in a knob. | Described for moderate to severe prolapse of the womb or vault (NHS leaflet); higher grades of prolapse (GLOWM). | Gloucestershire Hospitals NHS FT leaflet; Thakar, GLOWM |
| Donut | Silicone (NHS leaflet). Soft, but its shape is difficult to alter (GLOWM). | Described for severe prolapse of the womb (procidentia) (NHS leaflet); more severe stages (GLOWM). | Gloucestershire Hospitals NHS FT leaflet; Thakar, GLOWM |
| Shelf | Hard plastic device (NHS leaflet). | Described as providing extra support for the womb or vagina (NHS leaflet). | Gloucestershire Hospitals NHS FT leaflet |
Terminology differs between sources. The GLOWM chapter says support pessaries “lie along the vaginal axis providing a supportive shelf for the descending pelvic organs”; it does not use the phrase “shelf pessary”, so do not read the two as the same label. For ring sizing, see pessary sizes.
What is the regulatory status in the United States?
The FDA regulates vaginal pessaries under 21 CFR 884.3575 as Class II (performance standards) devices. In the openFDA device classification database the entry is “Pessary, Vaginal”, product code HHW, in the Obstetrics/Gynecology review panel, and it is not flagged as an implant (data updated 2026-10-19, checked 2026-10-30). The same database holds 41 premarket notification (510(k)) records for product code HHW as of 2026-10-30; openFDA states its data are unvalidated and not for medical decisions. For background, see the guides on FDA device classification and 510(k)/PMA routes, 510(k) premarket notification and what counts as a medical device.
Handling basics
A pessary is a removable device. Follow the manufacturer’s instructions for use for the specific product. This page does not give fitting or removal instructions.
Common mix-ups
- Gellhorn vs donut: both are silicone, but the Gellhorn has a stem and knob on a concave base, while the donut is described as a soft silicone device.
- Shelf vs support pessary: the NHS leaflet uses “shelf” for a hard plastic type, while GLOWM uses “support pessaries” as a broader group. Check which sense a document uses before comparing.
Clinics and buyers looking for related items can browse the gynecology and urology supplies category.
FAQ
Is a Gellhorn pessary the same as a donut pessary?
No. Both are silicone, but the Gellhorn has a circular base with a stem ending in a knob, while the donut is described as soft and silicone (NHS leaflet and GLOWM, checked 2026-10-30).
What is a shelf pessary?
The Gloucestershire NHS leaflet describes it as a hard plastic device that provides extra support for the womb or vagina.
Is a Gellhorn pessary an FDA-regulated device?
Yes. Vaginal pessaries are Class II devices under 21 CFR 884.3575, product code HHW.
Sources
- 21 CFR 884.3575, Vaginal pessary: https://www.law.cornell.edu/cfr/text/21/884.3575, checked 2026-10-30.
- openFDA device classification and 510(k) records, product code HHW: https://api.fda.gov/device/classification.json?search=product_code:HHW, checked 2026-10-30.
- Gloucestershire Hospitals NHS Foundation Trust, “Vaginal pessary for pelvic organ prolapse” patient leaflet: https://www.gloshospitals.nhs.uk/your-visit/patient-information-leaflets/vaginal-pessary-for-pelvic-organ-prolapse/, checked 2026-10-30.
- Thakar R., “Pessaries for Treatment of Pelvic Organ Prolapse”, Global Library of Women’s Medicine, DOI 10.3843/GLOWM.10479: https://www.glowm.com/section-view/heading/Pessaries-for-Treatment-of-Pelvic-Organ-Prolapse/item/805, last updated July 2014, checked 2026-10-30.
