HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
FDA 510(k) clearance K132658 · decided 2013-11-27
Clearance details
- K-number
- K132658
- Device name
- HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
- Applicant
- Teleflex Medical
- Decision
- Substantially Equivalent
- Date received
- 2013-08-26
- Decision date
- 2013-11-27
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general recall (Z-1663-2023) | TELEFLEX LLC | 2023-05-30 |