FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARPATH 24
K Number: K112318
·
Decision Jun 29, 2012
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
16
Review Days
323
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Basic Information
- Device Name
- CLEARPATH 24
- K Number
- K112318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedic, Inc.
- Date Received
- August 11, 2011
- Decision Date
- June 29, 2012
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Promedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131889 | EUM 100PRO | Apr 23, 2014 | Substantially Equivalent |
| K072756 | NON-IV ADAPTER FOR INFANT NG TUBE | Dec 19, 2007 | Unknown |
| K060497 | BABYAIR | Jul 11, 2006 | Substantially Equivalent |
| K060842 | REVJET TURBO | Jun 21, 2006 | Substantially Equivalent |
| K052903 | PEDIATRIC FEEDING TUBE | Nov 9, 2005 | Substantially Equivalent |
| K031409 | URINARY CATHETERS | Jun 17, 2003 | Substantially Equivalent |
| K024190 | FENESTRATED INFUSION CATHETER | Mar 17, 2003 | Substantially Equivalent |
| K023579 | GAS SAMPLING LINES | Jan 28, 2003 | Substantially Equivalent |
| K020005 | INFANT FEEDING TUBES | Jul 16, 2002 | Substantially Equivalent |
| K970102 | FILTER | Jun 24, 1997 | Substantially Equivalent |