FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE HEMOSTASIS CHIP
K Number: K121505
·
Decision Aug 31, 2012
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
56
Applicant Total
2
Review Days
102
Basic Information
- Device Name
- DISPOSABLE HEMOSTASIS CHIP
- K Number
- K121505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
- Date Received
- May 21, 2012
- Decision Date
- August 31, 2012
- Product Code
- PKL
- 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 |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
| K Number | Device Name | ||
|---|---|---|---|
| K111895 | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE | Apr 27, 2012 | Substantially Equivalent |