FDA 510(k)

Instrument tray, for semi-rigid ureteroscope

K-Nummer: K203492 · 2021-09-15

Entscheidungsdatum2021-09-15

ProduktcodeKCT

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Instrument tray, for semi-rigid ureteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K203492. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Instrument tray, for semi-rigid ureteroscope?

Instrument tray, for semi-rigid ureteroscope is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K203492.

When did Instrument tray, for semi-rigid ureteroscope receive FDA 510(k) clearance?

Instrument tray, for semi-rigid ureteroscope received FDA 510(k) clearance on 2021-09-15, under 510(k) number K203492.

Who is the listed applicant for Instrument tray, for semi-rigid ureteroscope?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instrument tray, for semi-rigid ureteroscope?

The FDA product code for Instrument tray, for semi-rigid ureteroscope is KCT.

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 Olympus Winter & Ibe GmbH als Antragsteller

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)K221522HF-cables (resusable)K223183Light-Guide Cables K213207Sheath, Stopcock Accessory

Alle 22 Geräte anzeigen →

Verwandte Geräte (Code: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

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.