Written and maintained by CASRAI Editorial Board
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General product and regulatory information only. This page is not medical advice and does not describe how any instrument is used on a patient.
Short answer
A surgical curette is a hand-held, nonpowered instrument used in surgery; there is no single FDA record for it. In the United States the general-use curette is a Class I device (product code FZS) under 21 CFR 878.4800, exempt from premarket notification, while dental, ear-nose-throat, gynecologic and ophthalmic curettes are classified under their own regulations. Check the product code before assuming which family a catalogue item belongs to.
Definition and scope
21 CFR 878.4800 defines a manual surgical instrument for general use as “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” Its list of included devices names the curette alongside the chisel, elevator, file, forceps, osteotome, retractor and others (eCFR, version dated 2026-10-01, checked 2026-10-31). The same paragraph adds that “a surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations.”
That sentence is the key to the whole topic. The word “curette” appears in many separate FDA classification entries, and the regulation defines the device by what it is and where it is used, not by tip shape or handle. The identification text in 878.4800 does not specify a tip shape, size or sharpness, so those attributes come from the manufacturer’s product record rather than from the regulation.
How it is described in practice
FDA’s product classification database (openFDA, checked 2026-10-31) lists product code FZS as “Curette, Surgical, General Use”: Class I, regulation 878.4800, review panel General and Plastic Surgery, not an implant, not life-sustaining. The record is 510(k)-exempt, and its GMP-exempt flag is “N”, so exemption from premarket notification is not exemption from quality system requirements. A second entry, HTF (“Curette”), sits under the same regulation and class.
Clinical technique is outside the scope of this page; it belongs to trained clinicians, institutional protocols and the manufacturer’s instructions for use.
Surgical curette types by specialty and regulation
The table lists every curette entry returned by the openFDA classification database for the search term “curette” (checked 2026-10-31), grouped by regulation. It is a map of regulatory families, not a ranking.
| Specialty | FDA product name (code) | Regulation | Class |
|---|---|---|---|
| General use | Curette, Surgical, General Use (FZS); Curette (HTF) | 21 CFR 878.4800 | Class I |
| Dental | Curette, Surgical, Dental (EMK); Curette, Operative (EKE); Curette, Endodontic (EKT); Curette, Periodontic (EMS) | 21 CFR 872.4565 | Class I |
| Ear, nose, throat | Curette, Ear (JYG); Curette, Nasal (KAP); Curette, Ethmoid (KAO); Curette, Adenoid (KBJ); Curette, Salpingeal (KBK) | 21 CFR 874.4420 | Class I |
| Obstetrics and gynecology | Curette, Uterine (HCY) | 21 CFR 884.4530 | Class I |
| Ophthalmic | Curette, Ophthalmic (HNZ) | 21 CFR 886.4350 | Class I |
| Obstetrics and gynecology (suction) | Curette, Suction, Endometrial and Accessories (HHK) | 21 CFR 884.1175 | Class II |
| Ear, nose, throat (bronchoscope biopsy) | Curette, Biopsy, Bronchoscope, Rigid (JEL) and Non-Rigid (BST) | 21 CFR 874.4680 | Class II |
General-use and dental
The general-use entry is described above. Dental curettes are named in 21 CFR 872.4565, whose list of dental hand instruments includes the endodontic curette, operative curette, periodontic curette and surgical curette as separate names. Our guide to dental surgical instruments covers that list.
Ear, nose and throat
21 CFR 874.4420 names the adenoid curette, salpingeal curette, nasal curette and ear curette among its instruments. See the guides to the adenoid curette, ear picks, scoops and ear curettes and ENT surgical instruments.
Gynecologic, dermal and other families
21 CFR 884.4530 defines the uterine curette as “an instrument used to scrape and remove material from the uterus” (see uterine curette). Ophthalmic curettes appear in the 21 CFR 886.4350 list. For skin curettes, see dermal curette.
Where it matters for labs, clinics and supply records
Two instruments both called a “curette” in a catalogue can sit in different regulatory classes. The two Class II rows in the table, suction endometrial curettes and bronchoscope biopsy curettes, are the exceptions to the Class I pattern, so the class cannot be assumed from the word alone. Use the checklist below, built only from fields that FDA classification records and the regulation text actually carry.
Checklist for reading a curette product record
| Field to read | Why it matters |
|---|---|
| Device name on the record | The FDA name decides the family: “Curette, Surgical, General Use” and “Curette, Surgical, Dental” are different entries. |
| Product code | FZS or HTF points to 21 CFR 878.4800; EMK, EKE, EKT or EMS to dental; KBJ, KAP, KAO, KBK or JYG to ENT; HCY to uterine. |
| Regulation number and class | A Class I entry under 878.4800 is exempt from premarket notification subject to 21 CFR 878.9. Suction and bronchoscope-biopsy curettes sit in Class II. |
| Reusable or disposable | 21 CFR 878.4800 covers instruments “either reusable or disposable”, so the regulation does not settle this; the manufacturer’s product information must. |
| Sterility and reprocessing | The classification regulation does not set these; look to the manufacturer’s labeling and instructions for use. |
Common misunderstandings
- “Curette” means one regulated device. It does not; the table shows seven regulations and two classes using the word.
- Curette, spoon and scoop are the same name. FDA lists “Curette, Ear” (JYG) and “Spoon, Ear” (JZE) as separate entries, and “Scoop” (FHL) under a different regulation, 21 CFR 876.4730.
- Class I exempt means no obligations. The 510(k) exemption is subject to the limitations in 21 CFR 878.9, and the FZS record’s GMP-exempt flag is “N”.
- General use means any specialty. The regulation says specialty-specific instruments are classified separately.
FAQ
What are the types of surgical curette?
In FDA’s classification, curettes fall into general-use, dental (operative, endodontic, periodontic and surgical), ear-nose-throat (ear, nasal, ethmoid, adenoid, salpingeal), uterine, ophthalmic, suction endometrial and bronchoscope biopsy families. Each has its own product code and regulation.
How does FDA classify a surgical curette?
The general-use curette (FZS) is Class I under 21 CFR 878.4800 and exempt from premarket notification, subject to 21 CFR 878.9. Suction endometrial and bronchoscope biopsy curettes are Class II.
Sources
- 21 CFR 878.4800, Manual surgical instrument for general use (eCFR, version dated 2026-10-01, checked 2026-10-31).
- 21 CFR 872.4565, 874.4420, 884.4530 and 886.4350 (eCFR, same version, checked 2026-10-31).
- openFDA device classification API, product codes FZS, HTF, EMK, EKE, EKT, EMS, JYG, KAP, KAO, KBJ, KBK, HCY, HNZ, HHK, JEL, BST, JZE, FHL (checked 2026-10-31).
