Wallaby Avenir Coil System
FDA 510(k) K173711 · Wallaby Medical, Inc.
510(k) numberK173711
Submission
- Device name
- Wallaby Avenir Coil System
- Applicant
- Wallaby Medical, Inc.
Laguna Hills, CA, US - Received
- December 4, 2017
- Decision date
- May 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | Cerenovus, Inc. | 08/14/2026SE |
| K261772 | Target Xtra Detachable CoilHCG · Special | Stryker Neurovscular | 06/24/2026SE |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | Balt USA, LLC | 01/27/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | Stryker Neurovascular | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | Stryker Neurovascular | 10/17/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | Balt USA, LLC | 09/26/2025SE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
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| K254071 | p17 XR MicrocatheterQJP · Traditional | 08/18/2026SE |
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| K232437 | Paragon 8F Balloon Guide CatheterDQY · Traditional | 10/13/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | 04/25/2023SE |
| K222603 | 6F Wallaby Long SheathDQY · Traditional | 03/02/2023SE |
| K211697 | Esperance Aspiration Catheter SystemNRY · Traditional | 11/16/2021SE |
Questions and answers
When was Wallaby Avenir Coil System cleared by the FDA?
Wallaby Avenir Coil System (K173711) received a 510(k) decision of Substantially Equivalent on May 4, 2018, 151 days after the submission was received.
What is the product code of K173711?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.