FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K Number: K895900
·
Decision Jan 11, 1990
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
12
Applicant Total
91
Review Days
97
Basic Information
- Device Name
- WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
- K Number
- K895900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- WILSON-COOK MEDICAL, INC.
- Date Received
- October 6, 1989
- Decision Date
- January 11, 1990
- Product Code
- FCK
- 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 |
|---|---|---|---|
| FCK | Instrument, Biopsy, Suction | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCK), ordered by most recent decision date.
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DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
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MEHTA BRONCHIAL BIOSPY DRILL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by WILSON-COOK MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K160890 | Howell Biliary Introducer Needle | Jun 14, 2017 | Substantially Equivalent |
| K162142 | Accessory Irrigation Adapter | Apr 27, 2017 | Substantially Equivalent |
| K153763 | Howell Biliary Aspiration Needle | Apr 6, 2017 | Substantially Equivalent |
| K161203 | Soehendra Stent Retriever | May 4, 2016 | Substantially Equivalent |
| K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON | Jul 19, 2010 | Substantially Equivalent |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | Jan 5, 2007 | Substantially Equivalent |
| K052051 | OMNI SPHINCTEROTOME | Aug 5, 2005 | Substantially Equivalent |
| K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE | May 11, 2005 | Substantially Equivalent |
| K040930 | ZILVER BILIARY STENT SYSTEM USW | Jul 2, 2004 | Unknown |
| K040800 | WILOSN-COOK BILIARY DILATION BALLOON | Jun 25, 2004 | Substantially Equivalent |