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FDA 510(k)

InZone Detachment System

K-Number: K212455 · 2021-11-16

ApplicantStryker Neurovascular
Decision Date2021-11-16
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

InZone Detachment System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2021-11-16 under 510(k) number K212455. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InZone Detachment System?

InZone Detachment System is a medical device that received FDA 510(k) clearance on 2021-11-16. The listed applicant is Stryker Neurovascular. The 510(k) number is K212455.

When did InZone Detachment System receive FDA 510(k) clearance?

InZone Detachment System received FDA 510(k) clearance on 2021-11-16, under 510(k) number K212455.

Who is the listed applicant for InZone Detachment System?

The FDA 510(k) record lists Stryker Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InZone Detachment System?

The FDA product code for InZone Detachment System is HCG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04195568Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter SystemACTIVE_NOT_RECRUITING

Other records listing Stryker Neurovascular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261889Trevo Trak 21 MicrocatheterPMA P170024Intracranial aneurysm flow diverterK253032AXS Lift Intracranial Base CatheterK252694Target Detachable CoilK251832InZone IST Detachment System; IZDS Connecting CablePMA P180031Intracranial coil-assist stent

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Related Devices (Code: HCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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