FDA 510(k)

easyPPHTM Hemorrhoidal Stapler for Single Use

K-Nummer: K183477 · 2019-02-11

Entscheidungsdatum2019-02-11

ProduktcodeGDW

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

easyPPHTM Hemorrhoidal Stapler for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K183477. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the easyPPHTM Hemorrhoidal Stapler for Single Use?

easyPPHTM Hemorrhoidal Stapler for Single Use is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K183477.

When did easyPPHTM Hemorrhoidal Stapler for Single Use receive FDA 510(k) clearance?

easyPPHTM Hemorrhoidal Stapler for Single Use received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183477.

Who is the listed applicant for easyPPHTM Hemorrhoidal Stapler for Single Use?

The FDA 510(k) record lists Ezisurg Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use?

The FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use is GDW.

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 Ezisurg Medical Co., Ltd. als Antragsteller

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Verwandte Geräte (Code: GDW)

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.