Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector— 510(k) K232004

Substantially Equivalent

Medivators (A Subsidiary of Steris Corporation)

FDA 510(k) clearance K232004 for Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector, Substantially Equivalent on 2024-03-06. Applicant: Medivators (A Subsidiary of Steris Corporation). Device class: 2.

Clearance details

Applicant
Medivators (A Subsidiary of Steris Corporation)
Product code
Code ODC
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Conroe, TX, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.