Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677
FDA 510(k) K051125 · Abbott Laboratories
510(k) numberK051125
Submission
- Device name
- Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677
- Applicant
- Abbott Laboratories
Redwood, CA, US - Received
- May 3, 2005
- Decision date
- June 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZP – Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K250643 | Disposable Polymer Ligation ClipsFZP · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 11/20/2025SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | Teleflex Medical | 07/03/2025SE |
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| K221495 | SOLID CLIP Single Use Clip ApplierFZP · Traditional | Medscope Biotech Co., Ltd. | 07/18/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
| K230966 | angiOCCLUDE Ligating ClipsFZP · Traditional | A2 Medical Systems, LLC | 09/19/2023SE |
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Questions and answers
When was Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677 cleared by the FDA?
Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677 (K051125) received a 510(k) decision of Substantially Equivalent on June 8, 2005, 36 days after the submission was received.
What is the product code of K051125?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.