Hysterectomy Forceps - (Several Models)
FDA 510(k) K891036 · Zinnanti Surgical Instruments, Inc.
510(k) numberK891036
Submission
- Device name
- Hysterectomy Forceps - (Several Models)
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- February 28, 1989
- Decision date
- March 17, 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 |
|---|---|---|
| K925501 | Nylon Coated SpeculaHIB · Traditional | 06/13/1997SE |
| K941458 | Uterine Manipulator/Injector with SpringLKF · Traditional | 01/25/1995SE |
| K941457 | Uterine Injector with SpringLKF · Traditional | 01/24/1995SE |
| K925560 | Zsi Loop, Zsi Ball & Zsi Needle ElectrodesHGI · Traditional | 08/30/1994SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | 04/07/1994SE |
| K925958 | Scissor for Laparoscopic Surgery Gu UseGCJ · Traditional | 03/24/1994SE |
| K926181 | Zsi Laparoscopes-General & Plastic SurgeryGCJ · Traditional | 12/17/1993SE |
| K926016 | Needle Holders & Access for Lapar Surg-Gu UseGCJ · Traditional | 11/12/1993SE |
Questions and answers
When was Hysterectomy Forceps - (Several Models) cleared by the FDA?
Hysterectomy Forceps - (Several Models) (K891036) received a 510(k) decision of Substantially Equivalent on March 17, 1989, 17 days after the submission was received.
What is the product code of K891036?
The FDA product code is HCZ – Forceps, Surgical, Gynecological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.