FDA device listing

CONNECTOR CLEANING J&J (20366),CONNECTOR CLEANING J&J (20375)

FDA device listing 1661752748 · HOYA Corporation PENTAX Division

Key facts

Proprietary names CONNECTOR CLEANING J&J (20366),CONNECTOR CLEANING J&J (20375)
Owner/operator HOYA Corporation PENTAX Division
Owner/operator number 8030235
Premarket submissions K832458
Product codes NVE
Device names NVE - Washer, Cleaner, Automated, Endoscope
Device class Class II
Classification regulations (21 CFR) 876.1500
Review panels Gastroenterology & Urology
Registered establishments PENTAX of America, Inc.
Establishment registrations 2518897
FEI numbers 1000080301
Establishment operations Complaint File Establishment
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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