HCY
11 FDA 510(k) clearances · Product code
90 daysmedian time to decision
146 days90th percentile
11clearances measured
FDA profile
- Official device name
- Curette, Uterine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1997: 1 · 1998: 1 · 2002: 2 · 2003: 1 · 2005: 2 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OAC (OPTICAL ASPIRATING CURETTE) (K980096) | Imagyn Medical Technologies, Inc. | 1998-05-01 |
| ENDOCYTE TM (K944238) | D.L. Nelson and Assoc., Inc. | 1995-09-15 |
| PHASE I CURETTE (K935822) | Phase I Corp. | 1994-04-28 |
| BAXTER D & C TRAY (K901442) | Baxter Healthcare Corp | 1990-07-26 |
| UTERINE CURETTE (K890384) | Kinetic Medical Products | 1989-02-13 |
| IVORY FINDER SET (K881794) | Ivory Instruments Co. | 1988-07-08 |
| THE D & C PAD-SAC (K862297) | Nu-Gyn-Tek, Inc. | 1986-07-07 |
| LUNE AU CURETTES (K850068) | Luneau Laboratories | 1985-04-08 |
| SURGICAL CURETTE, VARIOUS (K841004) | Premier Dental Products Co. | 1984-05-11 |
| UTERINE CURETTE (K802313) | Gynemetrics, Inc. | 1981-01-12 |
| DISPOSABLE VACUUM CURETTE (K790032) | British Marketing Ent., Ltd. | 1979-02-01 |
Track HCY automatically
Every clearance here is in the API, with alerts when new ones post.