Written and maintained by CASRAI Editorial Board
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Not medical advice. This page gives general product and regulatory information for laboratory, clinic and supply staff. It does not describe how to perform a procedure and is not a substitute for the manufacturer’s current instructions for use.
Short answer
A Savary dilator, sold by Cook Medical as the Savary-Gilliard Dilator, is a wire-guided esophageal dilator that a trained healthcare professional uses over a pre-positioned wire guide to dilate esophageal strictures. Under FDA rules it belongs to the esophageal dilator device type (21 CFR 876.5365), Class II and exempt from premarket notification. The Cook model is supplied non-sterile and is reusable.
Definition and scope
FDA’s regulation defines an esophageal dilator as a cylindrical instrument, which may be hollow, used to dilate a stricture of the esophagus. The regulation says this generic type includes esophageal or gastrointestinal bougies and the metal-olive esophageal dilator (21 CFR 876.5365(a), checked 30 October 2026). “Savary dilator” and “Savary-Gilliard dilator” are used for the same product family in searches; Cook’s instructions for use (IFU) name the device the Savary-Gilliard Dilator.
The Cook IFU states the intended use in one sentence: the device is used over a pre-positioned Savary-Gilliard wire guide for dilation of esophageal strictures. It also states that use is restricted to a trained healthcare professional and that the device should not be used for any other purpose.
How it is used in practice
The defining feature is the wire guide. The dilator has a wire guide lumen, so it travels over a wire that has already been placed rather than being passed on its own. The IFU lists contraindications specific to upper GI endoscopy as well as contraindications to dilation, and lists potential complications. These are clinical matters for the treating team; the complete lists and the procedure itself are in the manufacturer’s IFU, which this page does not reproduce.
Types and related device terms
The FDA regulation groups several instruments under one device type. The table lists only what the regulation and the Cook IFU state.
| Term | What the source says | Source |
|---|---|---|
| Esophageal dilator (metal olive) | Weighted with mercury or a metal olive-shaped weight that slides on a guide such as a string or wire | 21 CFR 876.5365(a) |
| Esophageal or gastrointestinal bougie | Named in the regulation as part of the same generic type | 21 CFR 876.5365(a) |
| Savary-Gilliard Dilator (Cook Medical) | Used over a pre-positioned wire guide; supplied non-sterile; reusable if device integrity is intact | Cook IFU 18851/0411 |
FDA’s classification database lists several product codes under this regulation, including KNQ (Dilator, Esophageal), EZM (Dilator, Esophageal, Metal Olive) and FAT (Bougie, Esophageal, and Gastrointestinal), all Class II (openFDA, checked 30 October 2026). Bougies used elsewhere in the body are different devices; see the CASRAI guide to the intubation bougie for one example, and the guide to ENT surgical instruments for another family of reusable instruments.
Where it matters for labs, clinics and supply decisions
Regulatory class
The device type is Class II (special controls) and exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 876.9. Exempt from premarket notification is not the same as unregulated; the type remains Class II. For background on the statute behind device classes, see Medical Device Amendments of 1976.
Reusable and non-sterile: reprocessing sits with the facility
Because the Cook IFU describes this device as supplied non-sterile and reusable, cleaning and disinfection between uses fall to the facility that holds it. The IFU (revision 0411, checked 30 October 2026) says reusability depends largely on the user’s care of the device, and sets these handling and labeling points:
- The device is supplied non-sterile and is reusable if its integrity is intact; the IFU asks users to inspect it for kinks, bends and breaks.
- The dilators cannot be autoclaved or gas sterilized.
- Betadine is not recommended for use on them.
- The IFU gives cleaning instructions and then high-level disinfection, and lists glutaraldehyde, ortho-phthalaldehyde (OPA), peracetic acid and hydrogen peroxide as disinfectant solutions for this device. It notes that discoloration may occur and is not harmful to the device.
- Store in a dry location away from temperature extremes.
Manufacturers revise IFUs, and a different revision may carry different reprocessing limits. A facility’s reprocessing procedure should follow the IFU that applies to the specific device it holds. For FDA’s reporting framework for device problems, see Medical Device Reporting (MDR).
Common misunderstandings
- “It is single-use.” The Cook Savary-Gilliard Dilator IFU describes it as reusable if device integrity is intact. Reusability is a property of the specific product’s IFU, not of the device type.
- “It arrives sterile.” The IFU states it is supplied non-sterile.
- “Any sterilizer will do.” The IFU states the dilators cannot be autoclaved or gas sterilized.
- “The wire guide is optional.” The stated intended use is over a pre-positioned wire guide.
- “Exempt means unregulated.” The regulation classifies the type as Class II; only the premarket notification step is exempted.
FAQ
What is a Savary dilator?
A wire-guided esophageal dilator. The Cook Medical version is the Savary-Gilliard Dilator, used over a pre-positioned wire guide to dilate esophageal strictures by a trained healthcare professional.
Is a Savary-Gilliard dilator the same as a Savary dilator?
The two names are used for the same product family. Cook’s labeling uses the name Savary-Gilliard Dilator.
What FDA class is it?
Class II (special controls) under 21 CFR 876.5365, exempt from premarket notification subject to 21 CFR 876.9.
Can it be reused?
Per Cook IFU revision 0411, yes, if device integrity is intact and it is cleaned and disinfected as the IFU describes. It cannot be autoclaved or gas sterilized.
Sources
- Cornell LII, eCFR text: 21 CFR 876.5365 Esophageal dilator, checked 30 October 2026.
- FDA, openFDA device classification database, product codes KNQ, EZM and FAT, checked 30 October 2026.
- Cook Medical, Savary-Gilliard Dilator instructions for use, 18851/0411, English section, checked 30 October 2026.
