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)

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES

K-Number: K112034 · 2011-08-12

ApplicantCarefusion 209, Inc.
Decision Date2011-08-12
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 209, Inc.. It received FDA 510(k) clearance on 2011-08-12 under 510(k) number K112034. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA ELITE DISPOSABLE CONCENTRIC NEEDLES?

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES is a medical device that received FDA 510(k) clearance on 2011-08-12. The listed applicant is Carefusion 209, Inc.. The 510(k) number is K112034.

When did TECA ELITE DISPOSABLE CONCENTRIC NEEDLES receive FDA 510(k) clearance?

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES received FDA 510(k) clearance on 2011-08-12, under 510(k) number K112034.

Who is the listed applicant for TECA ELITE DISPOSABLE CONCENTRIC NEEDLES?

The FDA 510(k) record lists Carefusion 209, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECA ELITE DISPOSABLE CONCENTRIC NEEDLES?

The FDA product code for TECA ELITE DISPOSABLE CONCENTRIC NEEDLES is IKT.

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 Carefusion 209, 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.

K120979CAREFUSION NICOLET EDXK112052CAREFUSION NICOLET EDXK111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESK103140NICOLET WIRELESS EEG

Related Devices (Code: IKT)

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.

K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed EuropeK173815Allergan Botox Needle ElectrodeNatus Manufacturing LimitedK161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing LimitedK152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLCK111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESCarefusion 209, Inc.

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.

↑