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)

MORE-L INJECTOR KIT PLUS

K-Number: K960619 · 1996-06-20

ApplicantIncutech, Inc.
Decision Date1996-06-20
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MORE-L INJECTOR KIT PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Incutech, Inc.. It received FDA 510(k) clearance on 1996-06-20 under 510(k) number K960619. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MORE-L INJECTOR KIT PLUS?

MORE-L INJECTOR KIT PLUS is a medical device that received FDA 510(k) clearance on 1996-06-20. The listed applicant is Incutech, Inc.. The 510(k) number is K960619.

When did MORE-L INJECTOR KIT PLUS receive FDA 510(k) clearance?

MORE-L INJECTOR KIT PLUS received FDA 510(k) clearance on 1996-06-20, under 510(k) number K960619.

Who is the listed applicant for MORE-L INJECTOR KIT PLUS?

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

What is the FDA product code for MORE-L INJECTOR KIT PLUS?

The FDA product code for MORE-L INJECTOR KIT PLUS is CAZ.

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 Incutech, Inc. 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.

K951870MORELL INJECTORK942394SAFE VENT SYSTEMK941731EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SETK940258SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)

Related Devices (Code: CAZ)

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.

K261372Profoject™ LOR SyringeCMT Health PTE., Ltd.K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLCK210983BD Epilor SyringeBecton, Dickinson and CompanyK201356Plastic LOR SyringeJiangsu Caina Medical Co.,LtdK202699E-Cath STIM acc. TsuiPAJUNK GmbH MedizintechnologieK190345VPCPAJUNK GmbH Medizintechnologie

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.

↑