Aesculap Slim Clip Applier
FDA 510(k) K180914 · Aesculap, Inc.
510(k) numberK180914
Submission
- Device name
- Aesculap Slim Clip Applier
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- April 9, 2018
- Decision date
- April 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K221524 | Sugita AVM Microclip ApplierHCI · Special | Mizuho America, Inc. | 06/24/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | Aesculap, Inc. | 12/13/2021SE |
| K173271 | Aesculap Slim Clip Applier ForcepsHCI · Special | Aesculap, Inc. | 11/10/2017SE |
| K010910 | Medicon Yasargil Clip Applying ForcepsHCI · Traditional | Medicon EG | 08/01/2001SE |
| K994191 | Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754THCI · Traditional | Nmt Medical, Inc. | 02/08/2000SE |
| K984109 | Aesculap Axial Clip ApplierHCI · Traditional | Aesculap, Inc. | 02/12/1999SE |
| K982379 | Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional | Johnson & Johnson Professionals, Inc. | 12/18/1998SE |
| K954658 | Perneczky Clip Applier/RemoverHCI · Traditional | Von Zeppelin GmbH | 10/08/1996SE |
| K940970 | Yasargil, Caspar, Vario Clip AppliersHCI · Traditional | Aesculap, Inc. | 01/24/1995SE |
| K902544 | Sundt Avm Micro ClipHCI · Traditional | Codman & Shurtleff, Inc. | 09/20/1990SE |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242762 | Aesculap Aicon® Series Container SystemKCT · Traditional | 05/13/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | 12/16/2024SE |
| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Aesculap Slim Clip Applier cleared by the FDA?
Aesculap Slim Clip Applier (K180914) received a 510(k) decision of Substantially Equivalent on April 17, 2018, 8 days after the submission was received.
What is the product code of K180914?
The FDA product code is HCI – Applier, Aneurysm Clip, a Class II (moderate risk) device regulated under 21 CFR 882.4175.