Gradtech Syringe System
FDA 510(k) K864732 · Gradtech
510(k) numberK864732
Submission
- Device name
- Gradtech Syringe System
- Applicant
- Gradtech
Tucson, AZ, US - Received
- December 4, 1986
- Decision date
- April 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243427 | QuickSleeper 5EGM · Traditional | Dentalhitec | 08/01/2025SE |
| K083811 | W&H Handpiece Anesto, Model: RA-5EGM · Traditional | W&H Dentalwerk Buermoos GmbH | 01/14/2010SE |
| K964802 | Cyberjet Local Anesthesia SystemEGM · Traditional | Intra Vantage, Inc. | 05/27/1997SE |
| K962017 | Hypodermic Jet Injection ApparatusEGM · Traditional | American Jet Injector Corp. | 07/26/1996SE |
| K904279 | Paroject Anesthetic SyringeEGM · Traditional | Ronvig Instruments, Ltd. | 12/07/1990SE |
| K864294 | Henke-Ject Pressure Syringe (Modification)EGM · Traditional | Smith & Nephew, Inc. | 11/04/1987SE |
| K864861 | Instrumentations Unlimited Syringe SystemEGM · Traditional | Instrumentations Unltd. | 02/13/1987SE |
| K834361 | JSB Jet SyringeEGM · Traditional | C.B.S. Biotechnics, Inc. | 03/05/1984SE |
| K821273 | Mayo Scissor Straight 6 3/4EGM · Traditional | Conphar, Inc. | 05/28/1982SE |
| K790193 | Mizzy Syrijet Mark IVEGM · Traditional | Mizzy, Inc. | 04/23/1979SE |
Questions and answers
When was Gradtech Syringe System cleared by the FDA?
Gradtech Syringe System (K864732) received a 510(k) decision of Substantially Equivalent on April 15, 1987, 132 days after the submission was received.
What is the product code of K864732?
The FDA product code is EGM – Injector, Jet, Mechanical-Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4475.