FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
K Number: K250066
·
Decision Feb 6, 2025
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
231
Review Days
27
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Basic Information
- Device Name
- Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
- K Number
- K250066
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- January 10, 2025
- Decision Date
- February 6, 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.
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
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OTSCneo System Set (100.03n-14n, 100.27n-31n)
FDA 510(k)
FDA Class 2
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Hemoclip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dual Action Tissue Closure Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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