FDA device listing

LOOK,Sharpoint

FDA device listing 1636088165 · Corza Medical Inc

Key facts

Proprietary names LOOK,Sharpoint
Owner/operator Corza Medical Inc
Owner/operator number 9060279
Premarket submissions K930826
Product codes GAP
Device names GAP - Suture, Nonabsorbable, Silk
Device class Class II
Classification regulations (21 CFR) 878.5030
Review panels General & Plastic Surgery
Registered establishments Surgical Specialties Mexico S DE RL DE CV
Establishment registrations 3010692967
FEI numbers 3010692967
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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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