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FDA 510(k)

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

K-Number: K151072 · 2016-01-22

ApplicantSolo-Dex, Inc.
Decision Date2016-01-22
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is the device name listed in this FDA 510(k) record. The listed applicant is Solo-Dex, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151072. 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 Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Solo-Dex, Inc.. The 510(k) number is K151072.

When did Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit receive FDA 510(k) clearance?

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151072.

Who is the listed applicant for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

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

What is the FDA product code for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit?

The FDA product code for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit 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.

NCT07052721Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot SurgeryCOMPLETEDNCT07638514Postoperative Analgesia Using a Perineural Catheter Versus a Single Nerve Block in Rearfoot SurgeryNOT_YET_RECRUITINGNCT03747146Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain ServiceRECRUITINGNCT06806709Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)RECRUITINGNCT06958731In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled TrialENROLLING_BY_INVITATIONNCT07629427Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency DepartmentCOMPLETED

Related Devices (Code: BSP)

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.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

Official Source

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