H.R. Jakobi Surg. Instruments #4 30/31
FDA 510(k) K834177 · Imm Enterprises , Ltd.
510(k) numberK834177
Submission
- Device name
- H.R. Jakobi Surg. Instruments #4 30/31
- 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
- HGE – Amniotome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951148 | Obsti-HookHGE · Traditional | Onli | 06/09/1995SE |
| K926425 | Amniperf(Tm)HGE · Traditional | Raymart Development Co. | 03/07/1994SE |
| K910518 | Glove-N-Gel Amniotomy KitHGE · Traditional | Epcom Medical Systems, Inc. | 05/09/1991SESK |
| K871087 | S.C.M.T. PerforatorHGE · Traditional | Salt Creek Medical Technologies | 03/23/1987SE |
| K850758 | Amniglove & AmnicotHGE · Traditional | Go Medical Industries Pty. , Ltd. | 04/15/1985SE |
More from Go Medical Industries Pty. , Ltd.
| 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. Instruments #4 30/31 cleared by the FDA?
H.R. Jakobi Surg. Instruments #4 30/31 (K834177) 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 K834177?
The FDA product code is HGE – Amniotome, a Class I (low risk) device regulated under 21 CFR 884.4530.