FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PADLOCK CLIP EFTR Kit (00713229)
K Number: K250842
·
Decision Apr 18, 2025
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
56
Applicant Total
169
Review Days
29
Basic Information
- Device Name
- PADLOCK CLIP EFTR Kit (00713229)
- K Number
- K250842
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- March 20, 2025
- Decision Date
- April 18, 2025
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKL), ordered by most recent decision date.
Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
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FDA Class 2
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PADLOCK CLIP EFTR Kit (00713229)
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Single Use Hemoclips
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Hemostatic Clips
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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