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)

ULTICARE DISPOSABLE SYRINGE 3 ML/CC

K-Number: K033794 · 2003-12-30

ApplicantUltimed, Inc.
Decision Date2003-12-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTICARE DISPOSABLE SYRINGE 3 ML/CC is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed, Inc.. It received FDA 510(k) clearance on 2003-12-30 under 510(k) number K033794. 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 ULTICARE DISPOSABLE SYRINGE 3 ML/CC?

ULTICARE DISPOSABLE SYRINGE 3 ML/CC is a medical device that received FDA 510(k) clearance on 2003-12-30. The listed applicant is Ultimed, Inc.. The 510(k) number is K033794.

When did ULTICARE DISPOSABLE SYRINGE 3 ML/CC receive FDA 510(k) clearance?

ULTICARE DISPOSABLE SYRINGE 3 ML/CC received FDA 510(k) clearance on 2003-12-30, under 510(k) number K033794.

Who is the listed applicant for ULTICARE DISPOSABLE SYRINGE 3 ML/CC?

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

What is the FDA product code for ULTICARE DISPOSABLE SYRINGE 3 ML/CC?

The FDA product code for ULTICARE DISPOSABLE SYRINGE 3 ML/CC 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 Ultimed, 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.

K100812ULTICARE DISPOSABLE PEN NEEDLESK080600ULTIMED ULTICARE SAFETY SYRINGEK081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINERK062702ULTICARE DISPOSABLE SYRINGES AND NEEDLESK050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2K021983ULTI GUARD HOME INSULIN SYRINGE CONTAINER

View all 8 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.

↑