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 uterine curette is, in U.S. federal regulation, “an instrument used to scrape and remove material from the uterus” (21 CFR 884.4530(a)(4)). FDA classifies it as a Class I device under product code HCY, and Class I uterine curettes are exempt from premarket notification (510(k)), subject to the limitations in 21 CFR 884.9. Exemption from 510(k) is not an exemption from quality system requirements.
Definition and scope
21 CFR 884.4530 groups a set of obstetric-gynecologic specialized manual instruments used to perform “manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance.” The uterine curette is item (4) of 18 devices named in that paragraph. The regulation defines the device by its function, not by a handle shape, tip style or size, so many different catalogue products can fall under the same definition.
The page covers the device as a product category. It does not cover clinical technique. For the general category of curettes used on skin, see dermal curette, a separate device with its own regulation; for the specialty context, see what is obstetrics and gynecology.
How the device is classified and recorded
Two federal records describe the device, as checked on 2026-10-30.
- Classification record. FDA’s product classification database (via openFDA) lists device name “Curette, Uterine”, product code HCY, regulation number 884.4530, device class 1, medical specialty Obstetrics/Gynecology. The record’s GMP exempt flag is “N”, meaning the device is not flagged as exempt from the quality system requirements, and it is marked eligible for summary malfunction reporting.
- Premarket status. Paragraph (b)(2) of 21 CFR 884.4530 places the uterine curette in Class I and states that Class I devices in that paragraph are exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 884.9.
- Device identification records. Manufacturers list products in the Global Unique Device Identification Database, which openFDA exposes. The HCY product code had 2,090 records when checked.
For the surrounding legal framework, see the Medical Device Amendments of 1976 and Medical Device Reporting (MDR).
Types and related instruments
The same regulation defines several neighbouring instruments that are often confused with the curette. Each definition below is quoted or closely taken from 21 CFR 884.4530(a); the class is from the openFDA classification database.
| Instrument (product code) | Regulatory definition | FDA class |
|---|---|---|
| Uterine curette (HCY) | Instrument used to scrape and remove material from the uterus | 1 |
| Uterine sound (HHM) | Instrument used to determine the depth of the uterus by inserting it into the uterine cavity | 1 |
| Fixed-size cervical dilator (HDQ) | Any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix | 1 |
| Gynecological biopsy forceps (HFB) | Instrument with two blades and handles used for gynecological biopsy procedures | 1 |
| Cytological cervical spatula (HHT) | Blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina | 2 |
| Uterine tenaculum (HDC) | Hooklike instrument used to seize and hold the cervix or fundus | 2 |
| Uterine elevator (HDP) | Instrument inserted into the uterus used to lift and manipulate the uterus | 2 |
The classification database also holds separate product codes for D and C trays (PVR, class 2) and for a uterine endometrial biopsy injector cannula (PGK, class 2), which sit outside the single-instrument definition above.
What a product record specifies
Device records under HCY show which attributes a manufacturer states. Two examples from the database: an Aesculap listing describes a Recamier uterine curette as 11 3/4 in (300 mm), rigid, sharp, width 18 mm, non-sterile, reusable; a Novo Surgical listing describes a Sims (Thomas) curette as blunt, 11 in (27.9 cm), rigid, size #6, 14.0 mm.
From those records, the attributes a listing can carry are:
- overall length;
- rigid or malleable shaft;
- sharp or blunt working edge;
- width or size number;
- sterile or non-sterile as supplied;
- reusable or single-use.
In a 100-record sample of HCY entries, 58 were flagged single-use and 42 were not, so both single-use and reusable products are listed under the same code. In the same sample, 50 records were flagged as kits.
Where it matters for labs, clinics and supply decisions
- Reading a catalogue entry. Because the regulation defines function only, the product record, not the product name, is where length, edge, size and sterility are stated.
- Kits under the same code. Packs such as “D and C pack” listings from a manufacturer appear under HCY in the identification database, so a listing found by searching for the curette may be a kit rather than a single instrument.
- Quality system. The classification record’s GMP flag “N” means Class I status does not by itself remove a manufacturer’s quality system obligations.
Common misunderstandings
Is a uterine curette the same as a uterine sound?
No. The regulation defines the curette as a scraping instrument and the sound as an instrument used to determine the depth of the uterus. They have separate product codes (HCY and HHM), though both are Class I.
Does Class I mean no FDA requirements apply?
No. Class I uterine curettes are exempt from premarket notification, subject to 21 CFR 884.9 limitations, but the classification record does not flag them as exempt from GMP requirements.
Is a “curette” listing always one instrument?
No. Kit and tray listings share the product-code family with single instruments.
FAQ
What is a uterine curette?
A device the regulation defines as an instrument used to scrape and remove material from the uterus (21 CFR 884.4530(a)(4)).
What FDA class is a uterine curette?
Class I, product code HCY, regulation 21 CFR 884.4530, per FDA’s classification database and paragraph (b)(2) of the regulation.
Are uterine curettes reusable or single-use?
Both appear in the device identification database; the individual product record states which.
Sources
- 21 CFR 884.4530, Obstetric-gynecologic specialized manual instrument, Electronic Code of Federal Regulations: https://www.ecfr.gov/current/title-21/section-884.4530 (checked 2026-10-30).
- FDA product classification database via openFDA, product code HCY: https://api.fda.gov/device/classification.json?search=product_code:HCY (checked 2026-10-30). openFDA data is unvalidated.
- FDA device identification (UDI) records via openFDA, product code HCY: https://api.fda.gov/device/udi.json?search=product_codes.code:HCY (100-record sample checked 2026-10-30; record descriptions are manufacturer-supplied).
