Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0
FDA 510(k) K093679 · AtriCure, Inc.
510(k) numberK093679
Submission
- Device name
- Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0
- Applicant
- AtriCure, Inc.
West Chester, OH, US - Received
- November 27, 2009
- Decision date
- June 10, 2010
- 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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| 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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| 510(k) | Device | Decision |
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| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | 04/10/2025SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | 01/15/2025SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | 10/29/2024SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | 08/27/2024SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | 07/29/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | 02/13/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | 11/02/2023SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | 10/26/2023SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
Questions and answers
When was Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0 cleared by the FDA?
Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0 (K093679) received a 510(k) decision of Substantially Equivalent on June 10, 2010, 195 days after the submission was received.
What is the product code of K093679?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.