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)

ULTIMED ULTICARE SAFETY SYRINGE

K-Number: K080600 · 2008-06-25

ApplicantUltimed, Inc.
Decision Date2008-06-25
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTIMED ULTICARE SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed, Inc.. It received FDA 510(k) clearance on 2008-06-25 under 510(k) number K080600. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMED ULTICARE SAFETY SYRINGE?

ULTIMED ULTICARE SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2008-06-25. The listed applicant is Ultimed, Inc.. The 510(k) number is K080600.

When did ULTIMED ULTICARE SAFETY SYRINGE receive FDA 510(k) clearance?

ULTIMED ULTICARE SAFETY SYRINGE received FDA 510(k) clearance on 2008-06-25, under 510(k) number K080600.

Who is the listed applicant for ULTIMED ULTICARE SAFETY SYRINGE?

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 ULTIMED ULTICARE SAFETY SYRINGE?

The FDA product code for ULTIMED ULTICARE SAFETY SYRINGE is MEG.

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 NEEDLESK081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINERK062702ULTICARE DISPOSABLE SYRINGES AND NEEDLESK050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CCK021983ULTI GUARD HOME INSULIN SYRINGE CONTAINER

View all 8 devices →

Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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.

↑