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)

ALLISON MEDICAL INSULIN SYRINGE (AMIS)

K-Number: K984017 · 1999-03-04

ApplicantAllison Medical, Inc.
Decision Date1999-03-04
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALLISON MEDICAL INSULIN SYRINGE (AMIS) is the device name listed in this FDA 510(k) record. The listed applicant is Allison Medical, Inc.. It received FDA 510(k) clearance on 1999-03-04 under 510(k) number K984017. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLISON MEDICAL INSULIN SYRINGE (AMIS)?

ALLISON MEDICAL INSULIN SYRINGE (AMIS) is a medical device that received FDA 510(k) clearance on 1999-03-04. The listed applicant is Allison Medical, Inc.. The 510(k) number is K984017.

When did ALLISON MEDICAL INSULIN SYRINGE (AMIS) receive FDA 510(k) clearance?

ALLISON MEDICAL INSULIN SYRINGE (AMIS) received FDA 510(k) clearance on 1999-03-04, under 510(k) number K984017.

Who is the listed applicant for ALLISON MEDICAL INSULIN SYRINGE (AMIS)?

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

What is the FDA product code for ALLISON MEDICAL INSULIN SYRINGE (AMIS)?

The FDA product code for ALLISON MEDICAL INSULIN SYRINGE (AMIS) is FMF.

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 Allison Medical, 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.

K932001ALLISON MEDICAL SYRINGE

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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.

↑