FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTRA INJECTION NEEDLE
K Number: K061222
·
Decision Jul 3, 2006
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
88
Applicant Total
18
Review Days
62
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Basic Information
- Device Name
- INJECTRA INJECTION NEEDLE
- K Number
- K061222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medi-Globe Corp.
- Date Received
- May 2, 2006
- Decision Date
- July 3, 2006
- Product Code
- FBK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBK), ordered by most recent decision date.
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Other Clearances by Medi-Globe Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Jun 16, 2005 | Substantially Equivalent |
| K011261 | STONE EXTRACTOR BALLOON CATHETER | Nov 17, 2003 | Substantially Equivalent |
| K010714 | EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 | Jan 21, 2003 | Substantially Equivalent |
| K010549 | BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) | Jan 18, 2002 | Unknown |
| K990220 | MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM | Mar 31, 1999 | Substantially Equivalent |
| K953355 | GIP/MEID-GLOBE HOT BIOPSY FORCEPS | Apr 4, 1996 | Substantially Equivalent |
| K955558 | GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES | Feb 29, 1996 | Substantially Equivalent |
| K953827 | GIP/MEDI-GLOBE ERCP CATHETERS | Sep 1, 1995 | Substantially Equivalent |
| K941973 | GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES | Jun 30, 1995 | Substantially Equivalent |
| K943935 | GIP/MEDI-GLOBE POLYPECTOMY SNARES | May 26, 1995 | Substantially Equivalent |