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FDA 510(k)

JetCan® Pro Safety Huber Needle

K-Number: K242763 · 2025-05-02

ApplicantPfm Medical, Inc.
Decision Date2025-05-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JetCan® Pro Safety Huber Needle is a medical device manufactured by Pfm Medical, Inc.. It received FDA 510(k) clearance on 2025-05-02 under approval number K242763. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JetCan® Pro Safety Huber Needle?

JetCan® Pro Safety Huber Needle is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Pfm Medical, Inc.. The 510(k) number is K242763.

When was JetCan® Pro Safety Huber Needle approved by the FDA?

JetCan® Pro Safety Huber Needle received FDA 510(k) clearance on 2025-05-02, under approval number K242763.

What company makes JetCan® Pro Safety Huber Needle?

JetCan® Pro Safety Huber Needle is manufactured by Pfm Medical, Inc..

What is the FDA product code for JetCan® Pro Safety Huber Needle?

The FDA product code for JetCan® Pro Safety Huber Needle is FPA.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

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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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