Category 17-MICROBIOLOGY Devices
FDA 510(k) K840304 · Imm Enterprises , Ltd.
510(k) numberK840304
Submission
- Device name
- Category 17-MICROBIOLOGY Devices
- Applicant
- Imm Enterprises , Ltd.
Mchenry, IL, US - Received
- January 24, 1984
- Decision date
- May 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTD – Forceps
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051281 | The Needle CatcherHTD · Traditional | E.D.Medical , Ltd. | 09/08/2005SE |
| K974595 | Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974594 | Semkin Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974593 | Semkin Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | Marlo Surgical Technology | 10/23/1991SE |
| K911180 | Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K895212 | Tik ExtraktorHTD · Traditional | Instruments of Sweden, Inc. | 09/27/1989SE |
| K890373 | Hemorrhoidal ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890369 | Gall Stone ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890263 | Cilia ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
More from Kinetic 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 |
| 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 |
| K840310 | Category 6 Opthalmic DevicesHOB · Traditional | 03/16/1984SE |
Questions and answers
When was Category 17-MICROBIOLOGY Devices cleared by the FDA?
Category 17-MICROBIOLOGY Devices (K840304) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 98 days after the submission was received.
What is the product code of K840304?
The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.