Cat. 4-OBSTETRICS Gynecology Dev's
FDA 510(k) K840308 · Imm Enterprises , Ltd.
510(k) numberK840308
Submission
- Device name
- Cat. 4-OBSTETRICS Gynecology Dev's
- Applicant
- Imm Enterprises , Ltd.
Mchenry, IL, US - Received
- January 24, 1984
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOH – Instrument, Manual, General Obstetric-Gynecologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000212 | Ksea Chardonnes Morcellation KnifeKOH · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/21/2000SE |
| K921732 | Minor Lap SetKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K921730 | C-Section PackKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K892693 | Vaginal Specula: Cusco, Guttman, InfantKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 05/11/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | Simpson/Basye, Inc. | 05/11/1989SE |
| K891035 | Needle ExtensionsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/22/1989SE |
| K891049 | Zeppelin ScissorsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K863610 | The Ob-Gyn Concepts Vaginal AspiratorKOH · Traditional | Ob/Gyn Concepts, Ltd. | 01/07/1987SE |
| K823792 | Quartz Retractor/ProbeKOH · Traditional | American V. Mueller | 01/18/1983SE |
| K812204 | Uterine ManipulatorsKOH · Traditional | Reznik Instruments | 10/13/1981SE |
More from Reznik Instruments
| 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 Cat. 4-OBSTETRICS Gynecology Dev's cleared by the FDA?
Cat. 4-OBSTETRICS Gynecology Dev's (K840308) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 41 days after the submission was received.
What is the product code of K840308?
The FDA product code is KOH – Instrument, Manual, General Obstetric-Gynecologic, a Class I (low risk) device regulated under 21 CFR 884.4520.