FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANIMUS EZSERTER INFUSION SET INSERTER
K Number: K021700
·
Decision Jun 4, 2002
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
10
Review Days
12
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
- ANIMUS EZSERTER INFUSION SET INSERTER
- K Number
- K021700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Animas Corp.
- Date Received
- May 23, 2002
- Decision Date
- June 4, 2002
- Product Code
- KZH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZH), ordered by most recent decision date.
GripMate
FDA 510(k)
FDA Class 2
·General Hospital
AccuSert Needle Inserter
FDA 510(k)
FDA Class 2
·General Hospital
Orbit Inserter
FDA 510(k)
FDA Class 2
·General Hospital
MiniMed Quick-serter
FDA 510(k)
FDA Class 2
·General Hospital
WHISPERJECT AUTOINJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
LOBSTER AUTO-INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Animas Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | Jun 24, 2008 | Substantially Equivalent |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | May 15, 2008 | Substantially Equivalent |
| K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | Mar 30, 2007 | Substantially Equivalent |
| K042873 | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP | Dec 10, 2004 | Substantially Equivalent |
| K032257 | MODEL IR 1200 INSULIN PUMP | Oct 16, 2003 | Substantially Equivalent |
| K022394 | EZMANAGER PLUS | Jun 5, 2003 | Substantially Equivalent |
| K021439 | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO | May 29, 2002 | Substantially Equivalent |
| K012754 | EZ SET INFUSION SET | Aug 27, 2001 | Substantially Equivalent |
| K993184 | R1000 SERIES INSULIN PUMP | Feb 10, 2000 | Substantially Equivalent |