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)

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE

K-Number: K061492 · 2006-08-03

ApplicantTyco Healthcare
Decision Date2006-08-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare. It received FDA 510(k) clearance on 2006-08-03 under 510(k) number K061492. 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 MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE?

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2006-08-03. The listed applicant is Tyco Healthcare. The 510(k) number is K061492.

When did MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE receive FDA 510(k) clearance?

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE received FDA 510(k) clearance on 2006-08-03, under 510(k) number K061492.

Who is the listed applicant for MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE?

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

What is the FDA product code for MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE?

The FDA product code for MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE 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 Tyco Healthcare 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.

K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSORK070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662K042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETERK040897DOVER ROB-NEL CATHETERK040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE

View all 14 devices →

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.

↑