Curette, Uterine
The Uterine Curette is a manual gynecological surgical instrument with a spoon-shaped or loop-shaped end used to scrape or remove tissue from the inner lining of the uterus for diagnostic or therapeutic purposes, such as in dilation and curettage (D&C) procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HCY under regulation 21 CFR 884.4530 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
Research product code HCY in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HCY
- Device Class
- FDA class 1
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K980096 | OAC (OPTICAL ASPIRATING CURETTE) | May 01, 1998 | Substantially Equivalent | Imagyn Medical Technologies, Inc. |
| K944238 | ENDOCYTE TM | Sep 15, 1995 | Substantially Equivalent | D.L. Nelson and Assoc., Inc. |
| K935822 | PHASE I CURETTE | Apr 28, 1994 | Substantially Equivalent | Phase I Corp. |
| K901442 | BAXTER D & C TRAY | Jul 26, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K890384 | UTERINE CURETTE | Feb 13, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K881794 | IVORY FINDER SET | Jul 08, 1988 | Substantially Equivalent | Ivory Instruments Co. |
| K862297 | THE D & C PAD-SAC | Jul 07, 1986 | Substantially Equivalent | Nu-Gyn-Tek, Inc. |
| K850068 | LUNE AU CURETTES | Apr 08, 1985 | Substantially Equivalent | Luneau Laboratories |
| K841004 | SURGICAL CURETTE, VARIOUS | May 11, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K802313 | UTERINE CURETTE | Jan 12, 1981 | Substantially Equivalent | Gynemetrics, Inc. |
| K790032 | DISPOSABLE VACUUM CURETTE | Feb 01, 1979 | Substantially Equivalent | British Marketing Ent., Ltd. |
FEI Numbers
This FDA classification entry is associated with 129 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 129 registration numbers. Click on an entry to view related FDA registrations.