FDA applicant
Intec Medical, Inc.
FDA records 17 decisions for Intec Medical, Inc. (Blue Springs, MO) from 1980 to 1991: 17 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and BYX (Tubing, Pressure And Accessories). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Intec Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Intec Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Intec Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Intec”
FDA records each applicant name separately; these may or may not be the same firm.