Instrumentations Unlimited Syringe System
FDA 510(k) K864861 · Instrumentations Unltd.
510(k) numberK864861
Submission
- Device name
- Instrumentations Unlimited Syringe System
- Applicant
- Instrumentations Unltd.
Tucson, AZ, US - Received
- December 11, 1986
- Decision date
- February 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EGM
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|---|---|---|---|
| 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 |
| K864732 | Gradtech Syringe SystemEGM · Traditional | Gradtech | 04/15/1987SE |
| 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 |
More from Mizzy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910090 | Dimac WiresDYX · Traditional | 07/25/1991SE |
Questions and answers
When was Instrumentations Unlimited Syringe System cleared by the FDA?
Instrumentations Unlimited Syringe System (K864861) received a 510(k) decision of Substantially Equivalent on February 13, 1987, 64 days after the submission was received.
What is the product code of K864861?
The FDA product code is EGM – Injector, Jet, Mechanical-Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4475.