510(k) K032425
- Device
- INVISIJECT RESUSABLE AUTO-INJECTOR
- Applicant
- BIOGEN
- 510(k) number
- K032425
- Product code
- KZH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-05
- Date received
- 2003-08-06
- Regulation
- 880.6920
- Classification name
- Introducer, Syringe Needle
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Poirier
- Address
- 14 Cambridge Center Cambridge MA US 02142 02142
FDA Registration Numbers#
- 3002806818
- 1058602
- 1219205
- 3013188547
- 3002808086
- 9681821
- 8021764
- 3002958688
- 3013143994
- 2523167
- 3007020251
- 3004837462
- 3038138498
- 3008061617
- 3005581234
- 9616674
- 2244771
- 3030446844
- 3004111573
- 9710049
- 2243252
- 2243072
- 3027031650
- 3003974574
- 3003348846
- 3007115200
- 9681538
- 3007207906
- 2011171
- 2032227
- 3006126537
- 3003442380
- 3009566827
- 8021545
- 3005831843
- 3009327445
- 3021853802
- 3014585508
- 1110315
- 3002807090
Source Documents#
Other 510(k) Records For Product Code KZH #
| 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 |
Legacy Summary#
summary
FDA Review#
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