FDA device listing
DLP Suction Tube
FDA device listing 1089730973 · Medtronic, Inc.
Key facts
| Proprietary names | DLP Suction Tube |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K950754 |
| Product codes | GCY |
| Device names | GCY - Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4680 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Medtronic Grand Rapids, Medtronic Mexico S. de R.L. de CV, MEDTRONIC PERFUSION SYSTEMS |
| Establishment registrations | 2184009, 9617601, 3003955307 |
| FEI numbers | 1000116158, 3002534070, 3003955307 |
| Establishment operations | Manufacturer, Specification Developer |
| 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