FDA 510(k)

27G x 1/2 TW K-Pack Surshield Nadel (KN-S2713RBT)

K-Nummer: K243309 · 2025-05-29

Entscheidungsdatum2025-05-29

ProduktcodeFMI

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K243309. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)?

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Terumo Europe N.V.. The 510(k) number is K243309.

When did 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) receive FDA 510(k) clearance?

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) received FDA 510(k) clearance on 2025-05-29, under 510(k) number K243309.

Who is the listed applicant for 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)?

The FDA product code for 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) is FMI.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Terumo Europe N.V. als Antragsteller

K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)K230951Terumo Injection Filter Needle (NF-3013RBKE05M)K212095SurGuard3 Safety Hypodermic Needle K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

Alle 7 Geräte anzeigen →

Verwandte Geräte (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.