Miniclamps, Stabiliz., Fallopian Tube
FDA 510(k) K772229 · J. Sklar Mfg. Co., Inc.
510(k) numberK772229
Submission
- Device name
- Miniclamps, Stabiliz., Fallopian Tube
- Applicant
- J. Sklar Mfg. Co., Inc.
Walker, MI, US - Received
- December 6, 1977
- Decision date
- January 3, 1978
- 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 |
|---|---|---|
| K843693 | Jacobs High Vacuum Suction Unit 05-2570BTA · Traditional | 10/31/1984SE |
| K842112 | Tischler Cervical Biopsy Punch ForcepsHFB · Traditional | 07/03/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | 06/19/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | 09/14/1982SE |
| K802458 | Kevorkian-Younge Biopsy Curette #90-6611HFB · Traditional | 01/12/1981SE |
| K802457 | Kevorkian-Younge Biopsy Punch, #90-6610HFB · Traditional | 01/12/1981SE |
| K801273 | Magill Catheter Intro. ForcepsKOA · Traditional | 07/28/1980SE |
| K800441 | Rudd-Clinic Hemorrhoidal ForcepsKOA · Traditional | 04/08/1980SE |
| K790577 | Hemorrhoidal LigatorHCF · Traditional | 04/23/1979SE |
| K772230 | Cannula, Perfusion, Fallopian TubeLKF · Traditional | 01/03/1978SE |
Questions and answers
When was Miniclamps, Stabiliz., Fallopian Tube cleared by the FDA?
Miniclamps, Stabiliz., Fallopian Tube (K772229) received a 510(k) decision of Substantially Equivalent on January 3, 1978, 28 days after the submission was received.
What is the product code of K772229?
The FDA product code is HCZ – Forceps, Surgical, Gynecological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.