FDA device listing

Microbiology Brush

FDA device listing 1655647148 · Hobbs Medical Inc

Key facts

Proprietary names Microbiology Brush
Owner/operator Hobbs Medical Inc
Owner/operator number 1220592
Premarket submissions K893729
Product codes FDX
Device names FDX - Endoscopic Cytology Brush
Device class Class II
Classification regulations (21 CFR) 876.1500
Review panels Gastroenterology & Urology
Registered establishments HOBBS MEDICAL, INC.
Establishment registrations 1220592
FEI numbers 1220592
Establishment operations Manufacturer
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

Browse all FDA device listings