IQG · Adaptor, Holder, Syringe
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | IQG |
|---|---|
| Device Name | Adaptor, Holder, Syringe |
| Regulation | 21 CFR 890.5050 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073555 | INSULIN PROTECTOR | Medicool, Inc. | Jul 11, 2008 | SESE |
| K072174 | INSUCOZI INSULIN VIAL COVER | 41 Industries, LLC | Jan 25, 2008 | SESE |
| K063180 | ISECURE SYRINGE CARTRIDGE HOLDER | Hospira, Inc. | Dec 11, 2006 | SESE |
Top Applicants
- 41 Industries, LLC — 1 clearance
- Hospira, Inc. — 1 clearance
- Medicool, Inc. — 1 clearance
