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FDA 510(k)

Endoscopic Injection Needle

K-Number: K213239 · 2022-06-02

ApplicantBeijing Zksk Technology Co., Ltd.
Decision Date2022-06-02
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Injection Needle is a medical device manufactured by Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-02 under approval number K213239. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscopic Injection Needle?

Endoscopic Injection Needle is a medical device that received FDA 510(k) clearance on 2022-06-02. It is manufactured by Beijing Zksk Technology Co., Ltd.. The 510(k) number is K213239.

When was Endoscopic Injection Needle approved by the FDA?

Endoscopic Injection Needle received FDA 510(k) clearance on 2022-06-02, under approval number K213239.

What company makes Endoscopic Injection Needle?

Endoscopic Injection Needle is manufactured by Beijing Zksk Technology Co., Ltd..

What is the FDA product code for Endoscopic Injection Needle?

The FDA product code for Endoscopic Injection Needle is FBK.

Related Clinical Trials

NCT03654066 Botox or Botox With Esophageal Dilation in Patients With Achalasia ENROLLING_BY_INVITATION NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06606587 Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia COMPLETED NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Other Devices by Beijing Zksk Technology Co., Ltd.

K213217Disposable hemoclip K213222Disposable Polypectomy Snare K213223Multi-Band Ligator K231721Disposable Hot Biopsy Forceps K242192Disposable Sphincterotome

Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix Co., Ltd.

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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