FDA device listing

Clip, Scalp - DeRoyal

FDA device listing 2026975573 · DEROYAL INDUSTRIES, INC.

Key facts

Proprietary names Clip, Scalp - DeRoyal
Owner/operator DEROYAL INDUSTRIES, INC.
Owner/operator number 1044833
Premarket submissions K905433
Product codes HBO
Device names HBO - Clip, Scalp
Device class Class II
Classification regulations (21 CFR) 882.4150
Review panels Neurology
Registered establishments DEROYAL INDUSTRIES, INC.
Establishment registrations 1043214
FEI numbers 1043214
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

Browse all FDA device listings