Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INZONE DETACHMENT SYSTEM

K-Number: K120816 · 2012-04-17

ApplicantStryker
Decision Date2012-04-17
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INZONE DETACHMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2012-04-17 under 510(k) number K120816. The device is classified under product code KRD. It was reviewed by the CV 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 2012-04-17. The listed applicant is Stryker. The 510(k) number is K120816.

When did INZONE DETACHMENT SYSTEM receive FDA 510(k) clearance?

INZONE DETACHMENT SYSTEM received FDA 510(k) clearance on 2012-04-17, under 510(k) number K120816.

Who is the listed applicant for INZONE DETACHMENT SYSTEM?

The FDA 510(k) record lists Stryker 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 KRD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Stryker 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.

K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMK230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®K230754L12 LED Light Source with AIMK2306051788 4K Camera System with Advanced Imaging ModalityK2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)K2221301688 4K Camera System with Advanced Imaging Modality

View all 79 devices →

Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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.

↑