AnastoClip GC Closure System
FDA 510(k) K173323 · LeMaitre Vascular, Inc.
510(k) numberK173323
Submission
- Device name
- AnastoClip GC Closure System
- Applicant
- LeMaitre Vascular, Inc.
Burlington, MA, US - Received
- October 20, 2017
- Decision date
- March 8, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K253903 | InnoClip Disposable Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| K253781 | InnoClip Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| 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 |
| K242541 | Gem ZipclipFZP · Traditional | Synovis Micro Companies Alliance A Subsidiary of… | 01/15/2025SE |
| 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 |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | Ethicon Endo Surgery, LLC | 08/29/2023SE |
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| K152833 | Pruitt F3-S Polyurethane Carotid ShuntMJN · Traditional | 01/21/2016SE |
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| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | 04/10/2014SE |
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Questions and answers
When was AnastoClip GC Closure System cleared by the FDA?
AnastoClip GC Closure System (K173323) received a 510(k) decision of Substantially Equivalent on March 8, 2018, 139 days after the submission was received.
What is the product code of K173323?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.