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General product and regulatory information only; this is not medical advice and not a procedure guide. Follow the manufacturer’s instructions for use and your facility’s clinical policies.
Short answer
A stone basket is a urology device with an expandable wire basket near the tip, used through an endoscope to entrap and remove stones. In U.S. regulation it is a “ureteral stone dislodger” under 21 CFR 876.4680: Class II (special controls) and exempt from premarket notification (checked 2026-10-30).
Definition and scope
The U.S. Code of Federal Regulations does not use the phrase “stone basket.” Section 876.4680, titled “Ureteral stone dislodger,” describes the device as a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction, inserted through a cystoscope and used to entrap and remove stones from the ureter. It states that this generic type includes the metal basket and the flexible ureteral stone dislodger.
So “stone basket” and “stone retrieval basket” are everyday names for the basket form of a device that FDA regulates under a broader name. The regulation is about ureteral stones; it does not address other stone locations or other instrument families.
How it is used in practice
Per the regulation’s own identification text, the device is passed through a cystoscope and is used to entrap and remove ureteral stones. One manufacturer, Boston Scientific, describes its Zero Tip nitinol basket as designed for use in the kidney and ureter, with a tipless design that allows close stone approximation (manufacturer product page, checked 2026-10-30; a marketing page, not the instructions for use). Technique, indications and contraindications belong to the product labelling and to clinicians, and are outside the scope of this page.
Types and related terms
Stone retrieval basket
A common synonym for the basket form. FDA’s product classification database lists product code FFL as “dislodger, stone, basket, ureteral, metal” (checked 2026-10-30).
Stone dislodger
The regulatory umbrella term. FDA lists a second code, FGO, as “dislodger, stone, flexible.” Both codes sit under regulation 876.4680, are Class II, and are 510(k) exempt (checked 2026-10-30).
Stone forceps
The term “stone forceps” appears in searches alongside baskets, but the FDA product-code pages for FFL and FGO do not list it under 876.4680, so this page makes no regulatory claim about it. For a different forceps family, see Bonney forceps.
| Term | What the source says | Source |
|---|---|---|
| Ureteral stone dislodger | Regulatory name; Class II (special controls); exempt from premarket notification | 21 CFR 876.4680 |
| Dislodger, stone, basket, ureteral, metal (FFL) | Product code; Class 2; regulation 876.4680; 510(k) exempt | FDA Product Classification database |
| Dislodger, stone, flexible (FGO) | Product code; Class 2; regulation 876.4680; 510(k) exempt | FDA Product Classification database |
| Tipless nitinol basket | One manufacturer’s design description: flat distal surface and knotted basket tip | Boston Scientific product page |
Where it matters for labs, clinics and supply decisions
Names differ between a regulator, a manufacturer and a catalogue. This sourced checklist shows what each label means when reading a product listing or specification sheet:
- FDA name versus trade name. The regulation and product codes use “dislodger”; listings may say “basket.” Match on regulation number 876.4680 and the product code, not on the marketing name.
- Class and exemption. Both FFL and FGO are Class 2 and 510(k) exempt, but the exemption is subject to the limitations in 21 CFR 876.9, and being exempt from premarket notification is not an FDA endorsement of a particular product.
- Design features are manufacturer-described. “Tipless” or “knotted tip” are one maker’s wording; the labelling defines what the feature is and what it is indicated for.
- Size and length are labelled attributes. The Zero Tip page, for example, lists sizes in French (1.9, 2.4 and 3.0 Fr) and working lengths of 90 and 120 cm. Treat these as that product’s labelled values, not as a standard range.
- Indications live in the labelling. The manufacturer page defers to the product labelling for indications and contraindications.
- Guidance exists. FDA lists the guidance document “Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology” against both codes.
For related supply context, see the urology clinic supply checklist, the guide to ureteral stent sizes and the explainer on the JJ stent. For another endoscope-delivered stone-related device, see the choledochoscope guide.
Common misunderstandings
- “510(k) exempt means unregulated.” The device is still Class II with special controls, and the exemption is subject to 21 CFR 876.9.
- “Basket and dislodger are different devices.” The regulation treats the metal basket and the flexible dislodger as one generic type.
- “One basket spec applies to all.” Sizes, lengths and tip designs are set by each manufacturer’s labelling.
FAQ
What is a stone basket?
A device with an expandable wire basket near the tip, inserted through a cystoscope to entrap and remove ureteral stones. FDA classifies it as a ureteral stone dislodger (21 CFR 876.4680).
Is a stone retrieval basket the same as a stone dislodger?
The basket is one form. The regulation says the generic type includes the metal basket and the flexible ureteral stone dislodger.
What FDA class is a ureteral stone basket?
Class II (special controls), exempt from premarket notification subject to 21 CFR 876.9, per the regulation as checked 2026-10-30.
Sources
- eCFR, 21 CFR 876.4680, Ureteral stone dislodger: https://www.ecfr.gov/current/title-21/section-876.4680 (checked 2026-10-30).
- FDA Product Classification database, codes FFL and FGO: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=FFL and ?id=FGO (checked 2026-10-30).
- Boston Scientific, Zero Tip nitinol basket product page: https://www.bostonscientific.com/en-EU/products/retrieval-devices/zero-tip.html (checked 2026-10-30; marketing page, cited as one manufacturer’s example only).
