FDA 510(k)

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

K-Number: K151069 · 2016-02-05

Decision Date2016-02-05

Product CodeBSP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K151069. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K151069.

When did SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle receive FDA 510(k) clearance?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle received FDA 510(k) clearance on 2016-02-05, under 510(k) number K151069.

Who is the listed applicant for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

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

What is the FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

The FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is BSP.

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.

NCT07498621Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth ExtractionCOMPLETED NCT07791082Clinical Success of 12 mm Needle IANB in ChildrenNOT_YET_RECRUITING NCT04766684Clubfoot Tenotomy TrialCOMPLETED NCT06606587Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative AnesthesiaCOMPLETED NCT07548892Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in ChildrenNOT_YET_RECRUITING NCT07581249This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary TeethCOMPLETED

Other records listing Spectra Medical Devices, Inc. as applicant

K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford

Related Devices (Code: BSP)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.