Atlas FDA

InZone Detachment System

FDA 510(k) clearance K212455 · decided 2021-11-16

Clearance details

K-number
K212455
Device name
InZone Detachment System
Applicant
Stryker Neurovascular
Decision
Substantially Equivalent
Date received
2021-08-05
Decision date
2021-11-16
Days to decision
103 days
Clearance type
Traditional
Product code
HCG
Device class
2
Regulation number
882.5950
Medical specialty
Neurology
Advisory committee
Neurology
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Target Xtra Detachable Coil (K261772)Stryker Neurovscular2026-06-24
Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (K260351)MicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20
Optima Coil System (OptiOne Coil System) (K254221)Balt USA, LLC2026-01-27
Target Detachable Coil (K252694)Stryker Neurovascular2025-12-11
InZone IST Detachment System; IZDS Connecting Cable (K251832)Stryker Neurovascular2025-10-17
Optima Coil System (Optima Packing Coil System) (K252700)Balt USA, LLC2025-09-26
Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154)MicroPort NeuroTech (Shanghai) Co., Ltd.2024-09-30
Optima Coil System (OptiBlock Line Extension) (K242582)Balt USA, LLC2024-09-27
Target Detachable Coils (K242243)Stryker Neurovscular2024-08-29
Numen Coil Embolization System; NumenFR Detachment System (K232955)MicroPort NeuroTech (Shanghai) Co., Ltd.2024-01-10
Axium Detachable Coil; Axium Prime Detachable Coil (K233420)Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular2023-11-07
Penumbra LP Coil System (K230284)Penumbra, Inc.2023-10-25

Recalls involving this device

RecordFirmDate
INZONE DETACHMENT SYSTEM, REF: M00345100950 recall (Z-2552-2026)Stryker Neurovascular2026-06-24

PMA approvals by this applicant

RecordFirmDate
Surpass Streamline Flow Diverter (P170024/S024)Stryker Neurovascular2025-08-20
Neuroform Atlas® Stent System (P180031/S006)Stryker Neurovascular2025-06-24
Surpass Streamline Flow Diverter (P170024/S023)Stryker Neurovascular2025-05-30
Neuroform Atlas Stent System (P180031/S011)Stryker Neurovascular2025-05-09
Surpass Elite Flow Diverter System (P170024/S022)Stryker Neurovascular2025-02-12
Neuroform Atlas Stent System (P180031/S010)Stryker Neurovascular2024-12-09
Neuroform Atlas Stent System (P180031/S009)Stryker Neurovascular2024-11-18
Surpass Elite Flow Diverter System (P170024/S018)Stryker Neurovascular2024-10-16