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Surgical Instruments, G-U, Manual (And Accessories)
FDA product code KOA · Class 1 · Gastroenterology, Urology
666
Registered devices
37
Adverse events
6
Recalls
44
510(k) clearances
Devices with this code
Symmetry Surgical® — ASPEN SURGICAL PRODUCTS, INC.Gyrus ACMI — Gyrus ACMI, LLCCARDINAL HEALTH — Cardinal Health 200, LLCELMED INCORPORATED — ELMED INCORPORATEDMillennium — Avalign Technologies, Inc.ELMED — ELMED INCORPORATEDGyrus ACMI — Gyrus ACMI, LLCELMED INCORPORATED — ELMED INCORPORATEDSymmetry Glassman — ASPEN SURGICAL PRODUCTS, INC.ZOLL-DENTAL — Zoll-DentalELMED INCORPORATED — ELMED INCORPORATEDRigicon Stainless Steel Furlow Insertion Tool — Rigicon, Inc.Gyrus ACMI — Gyrus ACMI, LLCELMED — ELMED INCORPORATEDELMED — ELMED INCORPORATEDELMED — ELMED INCORPORATEDHNM MEDICAL — HNM STAINLESS, LLC.Novo Surgical — NOVO SURGICAL, INC.Novo Surgical — NOVO SURGICAL, INC.ELMED — ELMED INCORPORATEDELMED — ELMED INCORPORATEDGreenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.ELMED — ELMED INCORPORATEDELMED — ELMED INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2019-04-10 | Uromedica Inc. | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to caus |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the |
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