ISECURE SYRINGE CARTRIDGE HOLDER
FDA 510(k) clearance K063180 · decided 2006-12-11
Clearance details
- K-number
- K063180
- Device name
- ISECURE SYRINGE CARTRIDGE HOLDER
- Applicant
- Hospira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-19
- Decision date
- 2006-12-11
- Days to decision
- 53 days
- Clearance type
- Special
- Product code
- IQG
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Lake Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INSULIN PROTECTOR (K073555) | Medicool, Inc. | 2008-07-11 |
| INSUCOZI INSULIN VIAL COVER (K072174) | 41 Industries, LLC | 2008-01-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008) | Hospira, Inc. | 1999-01-29 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007) | Hospira, Inc. | 1996-09-05 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006) | Hospira, Inc. | 1996-01-04 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003) | Hospira, Inc. | 1995-12-15 |
| DEXTRAN HM 32 (P880028/S002) | Hospira, Inc. | 1990-11-15 |
| DEXTRAN HM 32 (P880028/S001) | Hospira, Inc. | 1989-12-29 |
| DEXTRAN HM 32% (P880028) | Hospira, Inc. | 1989-05-30 |