Op-Con Surgical Instruments #4
FDA 510(k) K834174 · Imm Enterprises , Ltd.
510(k) numberK834174
Submission
- Device name
- Op-Con Surgical Instruments #4
- Applicant
- Imm Enterprises , Ltd.
Mchenry, IL, US - Received
- November 21, 1983
- Decision date
- December 27, 1983
- 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 |
|---|---|---|
| K841387 | Weston Rectal SnareKOA · Traditional | 05/09/1984SE |
| K841386 | Kollmann Urethral DilatorKOE · Traditional | 05/09/1984SE |
| K840311 | Cat. 7-EAR, Nose & Throat DevicesKCP · Traditional | 05/09/1984SE |
| K840304 | Category 17-MICROBIOLOGY DevicesHTD · Traditional | 05/01/1984SE |
| K840318 | Cat. 14-CLINICAL Toxiology DevicesHTD · Traditional | 04/23/1984SE |
| K840305 | Category 1 Circulatory System DeviceDWS · Traditional | 04/23/1984SE |
| K840312 | Cat. 8 Dental DevicesEMG · Traditional | 04/05/1984SE |
| K834171 | Op-Con Surg. Instrument #3KOA · Traditional | 04/04/1984SE |
| K834192 | Jakobi Surg. Instruments #3 21/22/24KOA · Traditional | 03/22/1984SE |
| K834191 | Jakobi Surgical Instruments #3 17/18/19KOA · Traditional | 03/22/1984SE |
Questions and answers
When was Op-Con Surgical Instruments #4 cleared by the FDA?
Op-Con Surgical Instruments #4 (K834174) received a 510(k) decision of Substantially Equivalent on December 27, 1983, 36 days after the submission was received.
What is the product code of K834174?
The FDA product code is HCZ – Forceps, Surgical, Gynecological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.