FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
K Number: K010714
·
Decision Jan 21, 2003
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
464
Applicant Total
18
Review Days
683
Basic Information
- Device Name
- EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
- K Number
- K010714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDI-GLOBE CORP.
- Date Received
- March 9, 2001
- Decision Date
- January 21, 2003
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by MEDI-GLOBE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K061222 | INJECTRA INJECTION NEEDLE | Jul 3, 2006 | Substantially Equivalent |
| K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Jun 16, 2005 | Substantially Equivalent |
| K011261 | STONE EXTRACTOR BALLOON CATHETER | Nov 17, 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 |
| K943629 | GIP/MEDI-GLOBE PAPILLOTOME | May 26, 1995 | Substantially Equivalent |