FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hem-o-lok PurplePlus Large Polymer Ligating Clips
K Number: K251054
·
Decision Jul 3, 2025
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
172
Applicant Total
18
Review Days
90
Basic Information
- Device Name
- Hem-o-lok PurplePlus Large Polymer Ligating Clips
- K Number
- K251054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflex Medical
- Date Received
- April 4, 2025
- Decision Date
- July 3, 2025
- Product Code
- FZP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K233713 | Pilling Tracheostomy Tubes | Mar 22, 2024 | Substantially Equivalent |
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| K231924 | EZ-IO Intraosseous Vascular Access System | Jul 25, 2023 | Substantially Equivalent |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Apr 28, 2023 | Substantially Equivalent |
| K222279 | Rusch Intermittent Urethral Catheters | Aug 29, 2022 | Substantially Equivalent |
| K202492 | EZ-IO Intraosseous Vascular Access System | Mar 22, 2021 | Substantially Equivalent |