Home › Device types › PKE
Laparoscopic Cholecystectomy Kit
FDA product code PKE · Class 1 · General, Plastic Surgery
31
Registered devices
5
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
CARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCSTRADIS HEALTHCARE — STRADIS MEDICAL, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCSTRADIS HEALTHCARE — STRADIS MEDICAL, LLCCARDINAL HEALTH — Cardinal Health 200, LLCHenry Schein — HENRY SCHEIN, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCSTRADIS HEALTHCARE — STRADIS MEDICAL, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may r |
| 2020-04-13 | American Contract Systems | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
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