H.R. Jakobi Surg. Instr. #10 34/36
FDA 510(k) K834178 · Imm Enterprises , Ltd.
510(k) numberK834178
Submission
- Device name
- H.R. Jakobi Surg. Instr. #10 34/36
- Applicant
- Imm Enterprises , Ltd.
Mchenry, IL, US - Received
- November 21, 1983
- Decision date
- February 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891571 | Percussion HammerGWZ · Traditional | Sandal Surgico | 03/31/1989SE |
| K852716 | Taylor Percussion Hammer SS 410 or 420GWZ · Traditional | The Huxley Instrument Corp. | 07/26/1985SE |
| K851748 | 1/310, 1-320 Percussion Hammers,Taylor, DejerineGWZ · Traditional | Artiberia | 06/13/1985SE |
| K840314 | Cat 10-NEUROLOGY DeviceGWZ · Traditional | Imm Enterprises , Ltd. | 02/23/1984SE |
| K834170 | Op-Con Surg. Instrument #10GWZ · Traditional | Imm Enterprises , Ltd. | 02/23/1984SE |
| K810054 | Rica (Diagnostic Instruments)GWZ · Traditional | Robert I. Chien & Assoc., Inc. | 01/28/1981SE |
| K803148 | Conphar Percussion Hammer(Taylor)GWZ · Traditional | Conphar, Inc. | 01/08/1981SE |
| K803174 | Conphar Percussion Hammer(Buck Type)GWZ · Traditional | Conphar, Inc. | 12/30/1980SE |
| K791337 | Taylor Neurological HammerGWZ · Traditional | Amdia Medical Products | 08/03/1979SE |
| K791336 | Bucks Neurological HammerGWZ · Traditional | Amdia Medical Products | 08/03/1979SE |
More from Amdia Medical Products
| 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 H.R. Jakobi Surg. Instr. #10 34/36 cleared by the FDA?
H.R. Jakobi Surg. Instr. #10 34/36 (K834178) received a 510(k) decision of Substantially Equivalent on February 23, 1984, 94 days after the submission was received.
What is the product code of K834178?
The FDA product code is GWZ – Percussor, a Class I (low risk) device regulated under 21 CFR 882.1700.