FDA product code HCY: Curette, Uterine
HCY is the FDA product code for curette, uterine. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 11 510(k) submissions under HCY, from 11 different applicants. The average 510(k) review took 106 days (median 90). FDA has posted 1 recall for HCY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Curette, Uterine |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HCY clearance
Top HCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imagyn Medical Technologies, Inc. | 1 | 1998-05-01 |
| D.L. Nelson and Assoc., Inc. | 1 | 1995-09-15 |
| Phase I Corp. | 1 | 1994-04-28 |
| Baxter Healthcare Corp | 1 | 1990-07-26 |
| Kinetic Medical Products | 1 | 1989-02-13 |
6 more applicants have HCY clearances. See the full list in Caduvo.
Most recent HCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980096 | Imagyn Medical Technologies, Inc. | OAC (OPTICAL ASPIRATING CURETTE) | 1998-05-01 | 112 |
| K944238 | D.L. Nelson and Assoc., Inc. | ENDOCYTE TM | 1995-09-15 | 380 |
| K935822 | Phase I Corp. | PHASE I CURETTE | 1994-04-28 | 146 |
| K901442 | Baxter Healthcare Corp | BAXTER D & C TRAY | 1990-07-26 | 121 |
| K890384 | Kinetic Medical Products | UTERINE CURETTE | 1989-02-13 | 21 |
Recalls for HCY devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HCY?
HCY is the FDA product code for curette, uterine. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HCY?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HCY?
Across 11 cleared submissions the average was 106 days from receipt to decision (median 90).
Which companies have the most HCY clearances?
Imagyn Medical Technologies, Inc. (1); D.L. Nelson and Assoc., Inc. (1); Phase I Corp. (1); Baxter Healthcare Corp (1); Kinetic Medical Products (1).
Have HCY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HCY
- Run a recall and safety report across every HCY manufacturer
- Watch product code HCY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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