Product code KZH
- Device name
- Introducer, Syringe Needle
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6920
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243232 | GripMate | Synthon Hispania S.L. | 2024-12-02 |
| K213429 | AccuSert Needle Inserter | Emed Technologies Corporation | 2022-10-20 |
| K163400 | Orbit Inserter | Ypsomed AG | 2017-07-26 |
| K160860 | MiniMed Quick-serter | Medtronic Minimed | 2016-09-22 |
| K141384 | WHISPERJECT AUTOINJECTOR | Scandinavian Health Limited | 2014-09-12 |
| K124026 | LOBSTER AUTO-INJECTOR | Scandinavian Health Limited | 2013-09-13 |
| K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | Owen Mumford, Ltd. | 2012-10-15 |
| K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS | Elcam Medical Acal | 2012-02-09 |
| K082587 | AUTO-SAFETY INJECTOR-2 (ASI-2) | Medical House Products Limited | 2008-10-02 |
| K073476 | COMPACT AUTO-SAFETY INJECTOR (CASI) | Medical House (Asi) Limited | 2008-03-07 |
| K062339 | DERMOTHERAP GUN | Dermoequipos S.R.L. | 2007-02-05 |
| K063146 | ACCU-CHEK LINKASSIST | Disetronic Medical Systems AG | 2006-11-27 |
| K060141 | DAI-R | Shl Medical, USA | 2006-06-12 |
| K060389 | CONFIDOSE IM AUTO-INJECTOR | Pharma-Pen, Inc. | 2006-06-06 |
| K051667 | EZ-JECT | Indolor, Ltd. | 2005-09-27 |
| K050434 | SHL DISPOSABLE AUTOINJECTOR | Shl Medical, USA | 2005-06-24 |
| K033696 | PERSONAL INJECTOR | Union Medico Aps | 2005-02-16 |
| K042557 | INNOJECT AUTO-INJECTOR | Innoject, Inc. | 2004-11-08 |
| K032848 | MEDSAFE SYSTEM INSERTER | Medsolve Technologies, LLC | 2004-04-12 |
| K032425 | INVISIJECT RESUSABLE AUTO-INJECTOR | Biogen | 2003-11-05 |
| K021700 | ANIMUS EZSERTER INFUSION SET INSERTER | Animas Corp. | 2002-06-04 |
| K013362 | AUTOJECT 2 | Owen Mumford USA, Inc. | 2001-11-13 |
| K010377 | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 | Minimed, Inc. | 2001-04-05 |
| K000482 | MODIFICATION TO AUTOJECT MINI | Owen Mumford, Ltd. | 2000-03-06 |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | Owen Mumford USA, Inc. | 1999-11-10 |
| K992300 | QUICK-SERTER, MODEL 395 | Medtronic Minimed | 1999-07-29 |
| K991680 | SOFTINJECT | Androsystems Srl | 1999-06-03 |
| K981266 | AUTO-INJECTOR, SURE-INJECT 2000 | Mighty Mo, Corp. | 1998-07-14 |
| K974678 | B-D AUTO-INJECTOR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-29 |
| K974171 | COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS | Teva Medical, Ltd. | 1997-12-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B33919800010 | V-Cath | Neo Medical Inc. | 2026-03-27 |
| 05713495000138 | SKYTROFA Auto-Injector | Phillips-Medisize A/S | 2025-08-20 |
| 05713495000121 | SKYTROFA Auto-Injector | Phillips-Medisize A/S | 2025-08-20 |
| 47622436104100 | Glatopaject ® | AEROPHARM GmbH | 2025-08-19 |
| 57622436104114 | Glatopaject ® | AEROPHARM GmbH | 2025-08-19 |
| 00860010587317 | CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory | Vapocoolshot, Inc | 2025-08-01 |
| 00850037806126 | MODD1 Patient Welcome Kit | Modular Medical, Inc. | 2025-07-11 |
| 00850037806119 | MODD1 Starter Kit | Modular Medical, Inc. | 2025-07-11 |
| B33935290030 | NeoMagic | Neo Medical Inc. | 2025-01-22 |
| 00860006961510 | Coolject 1-3cc Syringe Holder Nozzle Accessory | Vapocoolshot, Inc | 2023-01-27 |
| 00643169705920 | Sil-serter™ | MEDTRONIC MINIMED, INC. | 2022-09-17 |
| 05713495000077 | Skytrofa Auto-Injector | Phillips-Medisize A/S | 2021-10-22 |
| 00355513192019 | Onpro kit | AMGEN INC. | 2019-09-24 |
| 57612799202398 | Extavia® Auto-Injector II | NOVARTIS PHARMACEUTICALS CORPORATION | 2018-09-24 |
| 07613117021979 | Orbit®Inserter | Ypsomed AG | 2017-10-09 |
| B33950290030 | V-Cath | Neo Medical Inc. | 2016-09-24 |
| B33950530030 | V-Cath | Neo Medical Inc. | 2016-09-24 |
| B339914080 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B339914100 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B339914110 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B339914120 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B3395000080 | V-Cath | Neo Medical Inc. | 2016-09-24 |
| B33940530030 | V-Cath | Neo Medical Inc. | 2016-09-24 |
| B33940290030 | V-Cath | Neo Medical Inc. | 2016-09-24 |
| B3394000080 | V-Cath | Neo Medical Inc. | 2016-09-24 |
| B33930580040 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B33930530030 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B33930290030 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B3393000080 | NeoMagic | Neo Medical Inc. | 2016-09-24 |
| B33919580040 | NeoMagic | Neo Medical Inc. | 2016-09-24 |