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)

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

K-Number: K951005 · 1995-05-04

ApplicantKenex , Ltd.
Decision Date1995-05-04
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) is the device name listed in this FDA 510(k) record. The listed applicant is Kenex , Ltd.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K951005. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)?

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is Kenex , Ltd.. The 510(k) number is K951005.

When did KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) receive FDA 510(k) clearance?

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) received FDA 510(k) clearance on 1995-05-04, under 510(k) number K951005.

Who is the listed applicant for KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)?

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

What is the FDA product code for KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)?

The FDA product code for KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) is IZQ.

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 Kenex , Ltd. 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.

K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)K951006KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)

Related Devices (Code: IZQ)

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.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

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.

↑