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Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
FDA product code FAT · Class 2 · Gastroenterology, Urology
232
Registered devices
36
Adverse events
2
Recalls
8
510(k) clearances
Devices with this code
M-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDPilling — TELEFLEX INCORPORATEDWeightRight® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDM-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDPilling — TELEFLEX INCORPORATEDM-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDM-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDPILLING — TELEFLEX INCORPORATEDM-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDM-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATEDM-Flex® — DIVERSATEK HEALTHCARE, INC.PILLING — TELEFLEX INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-05-11 | Stryker Endoscopy | The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body. |
| 2009-08-20 | Stryker Endoscopy | The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body. |
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