FDA 510(k)

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

K-Number: K113634 · 2012-02-14

Decision Date2012-02-14

Product CodeFBK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2012-02-14 under 510(k) number K113634. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INJEKT CYSTO FLEXIBLE INJECTION NEEDLE?

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 2012-02-14. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K113634.

When did INJEKT CYSTO FLEXIBLE INJECTION NEEDLE receive FDA 510(k) clearance?

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE received FDA 510(k) clearance on 2012-02-14, under 510(k) number K113634.

Who is the listed applicant for INJEKT CYSTO FLEXIBLE INJECTION NEEDLE?

The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INJEKT CYSTO FLEXIBLE INJECTION NEEDLE?

The FDA product code for INJEKT CYSTO FLEXIBLE INJECTION NEEDLE is FBK.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cook Ireland, Ltd. as applicant

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)K213946Compass BDS Biliary Stent K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

View all 31 devices →

Related Devices (Code: FBK)

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

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.