Gainor Medical Europe, Ltd.
Mcdonough, GA, US
Gainor Medical Europe, Ltd. appears in FDA device records in Mcdonough, GA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Gainor Medical Europe, Ltd. between 1990 and 1994. The busiest year on record is 1990, with 5. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 5 |
| 1991 | 4 |
| 1993 | 3 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K926448 | I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K931828 | CARELET SAFETY LANCET | FMK | Substantially Equivalent | |
| K931827 | CLEANLET, CLEANLET XL & KIDS | FMK | Substantially Equivalent | |
| K922441 | SURESEAL BANDAGE | KGX | Substantially Equivalent | |
| K913333 | I.V. PRIMING SET | FPA | Substantially Equivalent | |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | FMI | Substantially Equivalent | |
| K902420 | CATHETER, NASAL, OXYGEN | CAT | Substantially Equivalent | |
| K902564 | NEEDLE, DIALYSIS | FIE | Substantially Equivalent | |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | FJK | Substantially Equivalent | |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | KDH | Substantially Equivalent | |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | FMK | Substantially Equivalent | |
| K902417 | BAG, URINE | KNX | Substantially Equivalent | |
| K900306 | HEMODIALYSIS BLOOD LINES | KOC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- CATCannula, Nasal, Oxygen
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- FPASet, Administration, Intravascular
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- KGXTape And Bandage, Adhesive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain