FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STICK-GARD SAFETY NEEDLE
K Number: K890620
·
Decision Feb 28, 1989
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
16
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STICK-GARD SAFETY NEEDLE
- K Number
- K890620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ziehm International, Inc.
- Date Received
- February 7, 1989
- Decision Date
- February 28, 1989
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Verisafe Safety Sterile Needles (SSN)
FDA 510(k)
FDA Class 2
·General Hospital
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PRESSONE
FDA 510(k)
FDA Class 2
·General Hospital
Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Ziehm International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011292 | ZIEHM VISION | Jun 20, 2001 | Substantially Equivalent |
| K910455 | IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR | Feb 14, 1991 | Substantially Equivalent |
| K902196 | MODIFIED STICK-GARD SAFETY NEEDLE | Jun 26, 1990 | Substantially Equivalent |
| K894021 | MOBILE X-RAY UNIT | Sep 1, 1989 | Substantially Equivalent |
| K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK | Aug 28, 1989 | Substantially Equivalent |
| K882133 | MAMMO M | Sep 19, 1988 | Substantially Equivalent |
| K843311 | IV ADMIN. SET FOR MVP 1 INFUSION PUMP | Mar 13, 1985 | Substantially Equivalent |
| K842263 | MTP E.V. INFUSION PUMP | Jul 25, 1984 | Substantially Equivalent |
| K831407 | CARDIAC OUTPUT COMPUTER | Oct 14, 1983 | Substantially Equivalent |
| K830453 | IV ADMINISTRATION SETS - MVP INFUSION | Apr 30, 1983 | Substantially Equivalent |