Malleable Placenta Curette
FDA 510(k) K890387 · Kinetic Medical Products
510(k) numberK890387
Submission
- Device name
- Malleable Placenta Curette
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 23, 1989
- Decision date
- February 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HEX – Colposcope (And Colpomicroscope)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1630
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233043 | Smart Scope® CXHEX · Traditional | Periwinkle Technologies Pvt., Ltd. | 06/14/2024SE |
| K190187 | Gynescope SystemHEX · Traditional | Illumigyn , Ltd. | 05/08/2019SE |
| K182764 | Biop Digital ColposcopeHEX · Traditional | Biop Medical , Ltd. | 11/27/2018SE |
| K181034 | Pocket Colposcope SystemHEX · Traditional | Hadleigh Health Technologies, LLC | 09/21/2018SE |
| K170446 | LT-300 SD Digital Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 05/21/2017SE |
| K161871 | EVA (Enhanced Visual Assessment) SystemHEX · Traditional | Mobileodt , Ltd. | 12/19/2016SE |
| K160341 | Colposcope SystemHEX · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 09/14/2016SE |
| K160380 | LT-300 HDHEX · Traditional | Lutech Industries, Inc. | 05/13/2016SE |
| K151878 | Video ColposcopeHEX · Traditional | Edan Instruments, Inc. | 12/01/2015SE |
| K143119 | LT-300 Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 12/18/2014SE |
More from Lutech Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
| K890384 | Uterine CuretteHCY · Traditional | 02/13/1989SE |
Questions and answers
When was Malleable Placenta Curette cleared by the FDA?
Malleable Placenta Curette (K890387) received a 510(k) decision of Substantially Equivalent on February 27, 1989, 35 days after the submission was received.
What is the product code of K890387?
The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.