FDA device listing
Laproscopes
FDA device listing 1943372863 · ARTHREX, INC.
Key facts
| Proprietary names | Laproscopes |
|---|---|
| Owner/operator | ARTHREX, INC. |
| Owner/operator number | 1220287 |
| Premarket submissions | K941541 |
| Product codes | GCJ |
| Device names | GCJ - Laparoscope, General & Plastic Surgery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Arthrex Australia Pty Ltd., Arthrex Colombia SAS, Arthrex Distribution Hub EMEA B.V., Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda, Arthrex GmbH, Arthrex, Inc., ARTHREX, INC., Arthrex Japan G.K. (Shinjuku), Arthrex Korea Ltd., Arthrex Logistic Center Canada, Arthrex Mexico, S.A. de C.V., Arthrex (Shanghai) Co., Ltd. and 1 more |
| Establishment registrations | 1220246, 3002579136, 3010331645, 3011230048, 3012470322, 3013700547, 3014004349, 3014262693, 3015974593, 3016851379, 3019269298, 3021226419, 3030926959 |
| FEI numbers | 1220246, 3002579136, 3010331645, 3011230048, 3012470322, 3013700547, 3014004349, 3014262693, 3015974593, 3016851379, 3019269298, 3021226419, 3030926959 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 10–99 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