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FDA 510(k)

ULTRASHARP CONCENTRIC NEEDLES

K-Number: K080914 · 2008-07-15

ApplicantRochester Electro Medical, Inc.
Decision Date2008-07-15
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRASHARP CONCENTRIC NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Rochester Electro Medical, Inc.. It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K080914. 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 ULTRASHARP CONCENTRIC NEEDLES?

ULTRASHARP CONCENTRIC NEEDLES is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Rochester Electro Medical, Inc.. The 510(k) number is K080914.

When did ULTRASHARP CONCENTRIC NEEDLES receive FDA 510(k) clearance?

ULTRASHARP CONCENTRIC NEEDLES received FDA 510(k) clearance on 2008-07-15, under 510(k) number K080914.

Who is the listed applicant for ULTRASHARP CONCENTRIC NEEDLES?

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

What is the FDA product code for ULTRASHARP CONCENTRIC NEEDLES?

The FDA product code for ULTRASHARP CONCENTRIC NEEDLES is IKT.

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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, LLCK112034TECA ELITE DISPOSABLE CONCENTRIC 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.

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