FDA device listing

SHARPOINT

FDA device listing 1071192135 · Corza Medical, Inc.

Key facts

Proprietary names SHARPOINT
Owner/operator Corza Medical, Inc.
Owner/operator number 2242450
Product codes GES
Device names GES - Blade, Scalpel
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments KATENA PRODUCTS, INC.
Establishment registrations 2242450, 3015177648
FEI numbers 2242450, 3015177648
Establishment operations Repackager/Relabeler, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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