FDA device listing

PGA Rapid

FDA device listing 1024057984 · Weigao Group Company Limited

Key facts

Proprietary names PGA Rapid
Owner/operator Weigao Group Company Limited
Owner/operator number 10025293
Premarket submissions K183004
Product codes GAM
Device names GAM - Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class Class II
Classification regulations (21 CFR) 878.4493
Review panels General & Plastic Surgery
Registered establishments FOOSIN MEDICAL SUPPLIES INC.LTD
Establishment registrations 3006562124
FEI numbers 3006562124
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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