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FDA 510(k)

Promisemed Safety Huber Needle

K-Number: K230715 · 2023-06-08

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2023-06-08
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Promisemed Safety Huber Needle is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under approval number K230715. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promisemed Safety Huber Needle?

Promisemed Safety Huber Needle is a medical device that received FDA 510(k) clearance on 2023-06-08. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K230715.

When was Promisemed Safety Huber Needle approved by the FDA?

Promisemed Safety Huber Needle received FDA 510(k) clearance on 2023-06-08, under approval number K230715.

What company makes Promisemed Safety Huber Needle?

Promisemed Safety Huber Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Safety Huber Needle?

The FDA product code for Promisemed Safety Huber Needle is PTI.

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)

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle

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Related Devices (Code: PTI)

K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y siteB.Braun Medical, Inc. K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc. K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, 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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