Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip
FDA 510(k) K091987 · LeMaitre Vascular, Inc.
510(k) numberK091987
Submission
- Device name
- Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip
- Applicant
- LeMaitre Vascular, Inc.
Bedford, MA, US - Received
- July 2, 2009
- Decision date
- April 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code FZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating ClipsFZP · Traditional | Taiwan Surgical Corporation | 07/20/2026SE |
| 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 |
More from Ethicon Endo Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K212894 | PhasTIPPDWQ · Traditional | 03/31/2022SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | 02/13/2020SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | 10/30/2019SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | 06/13/2019SE |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt…MJN · Special | 11/16/2018SE |
| K173323 | AnastoClip GC Closure SystemFZP · Traditional | 03/08/2018SE |
| K152833 | Pruitt F3-S Polyurethane Carotid ShuntMJN · Traditional | 01/21/2016SE |
| K143454 | Pruitt F3-S Carotid ShuntMJN · Traditional | 08/27/2015SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | 10/17/2014SE |
| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | 04/10/2014SE |
Questions and answers
When was Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip cleared by the FDA?
Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip (K091987) received a 510(k) decision of Substantially Equivalent on April 23, 2010, 295 days after the submission was received.
What is the product code of K091987?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.