UTERINE CURETTE
FDA 510(k) clearance K890384 · decided 1989-02-13
Clearance details
- K-number
- K890384
- Device name
- UTERINE CURETTE
- Applicant
- Kinetic Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1989-01-23
- Decision date
- 1989-02-13
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HCY
- Device class
- 1
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Erie, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.