FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K Number: K133763
·
Decision May 15, 2014
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
7
Review Days
155
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Basic Information
- Device Name
- SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
- K Number
- K133763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medi-Globe Corporation
- Date Received
- December 11, 2013
- Decision Date
- May 15, 2014
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medi-Globe Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K153264 | EasyPass Guidewire | May 19, 2016 | Substantially Equivalent |
| K142258 | PolyCatch Retrieval Device | Sep 30, 2014 | Substantially Equivalent |
| K091257 | MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM | May 8, 2009 | Substantially Equivalent |
| K083802 | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 | Mar 20, 2009 | Substantially Equivalent |
| K070129 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Jan 31, 2007 | Substantially Equivalent |
| K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME | Jun 27, 2006 | Substantially Equivalent |