Adaptor, Holder, Syringe
A syringe holder adaptor is an assistive device used to hold and stabilize a syringe, enabling individuals with limited hand function to self-administer injections or manage syringes. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQG, regulated under 21 CFR 890.5050, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IQG
- Device Class
- FDA class 1
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073555 | INSULIN PROTECTOR | Jul 11, 2008 | Substantially Equivalent | Medicool, Inc. |
| K072174 | INSUCOZI INSULIN VIAL COVER | Jan 25, 2008 | Substantially Equivalent | 41 Industries, LLC |
| K063180 | ISECURE SYRINGE CARTRIDGE HOLDER | Dec 11, 2006 | Substantially Equivalent | Hospira, Inc. |
FEI Numbers
This FDA classification entry is associated with 77 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 77 registration numbers. Click on an entry to view related FDA registrations.