Uterine Dressing Forceps
FDA 510(k) K890378 · Kinetic Medical Products
510(k) numberK890378
Submission
- Device name
- Uterine Dressing Forceps
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 23, 1989
- Decision date
- February 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HCZ – Forceps, Surgical, Gynecological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HCZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172661 | Fetzer Medical Gynecological ForcepsHCZ · Traditional | Fetzer Medical GmbH & Co. KG | 05/08/2018SE |
| K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical…HCZ · Traditional | Integra LifeSciences Corporation | 04/11/2014SE |
| K092840 | Instrumed Forceps Obstetrical/GynaecologicalHCZ · Traditional | Instrumed International, Inc. | 12/03/2009SE |
| K944055 | Forceps, Surgical GynecologicalHCZ · Traditional | Owens Precision Systems, Inc. | 09/20/1994SE |
| K941528 | Pearl Packing ForcepsHCZ · Traditional | Cook Urological, Inc. | 05/12/1994SE |
| K926533 | Z-Clamp ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K926531 | Hysterectomy ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K926484 | Corson Myoma Grasping ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K930799 | Various ForcepsHCZ · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K930039 | Forceps: Mcgravey, Mcindoe, GillisHCZ · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
More from Thomasville Medical Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| 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 |
Questions and answers
When was Uterine Dressing Forceps cleared by the FDA?
Uterine Dressing Forceps (K890378) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 21 days after the submission was received.
What is the product code of K890378?
The FDA product code is HCZ – Forceps, Surgical, Gynecological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.