510(k) K833586 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
TLS BULB DRAINAGE SYSTEM
| Applicant | Porex Medical, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 30, 1984 |
| Received | Oct 12, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2017 | Stryker Leibinger GmbH & Co. KG QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile)
SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)
Accessories to TLS Surgical Drainage System Terminated |
GCY | None listed |
| Feb 8, 2017 | Stryker Leibinger GmbH & Co. KG 9805
Orbital Volume Sizer Set with Tray (Non-sterile)
9951
Design M Malar Sizer Set (Silicone, Non-Sterile)
9952
Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile)
85000
Petite Nasal Dorsum S Terminated |
GCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.