FDA 510(k)

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

K-Nummer: K230255 · 2023-03-28

AntragstellerStryker Sustainability Solutions

Entscheidungsdatum2023-03-28

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K230255. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019?

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K230255.

When did Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 receive FDA 510(k) clearance?

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K230255.

Who is the listed applicant for Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019?

The FDA product code for Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 is GEI.

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 Stryker Sustainability Solutions als Antragsteller

Alle 25 Geräte anzeigen →

Verwandte Geräte (Code: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., 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.