FDA applicant
Motus GI Medical Technologies, Ltd.
FDA records 7 decisions for Motus GI Medical Technologies, Ltd. (Tirat Carmel, IL) from 2016 to 2023: 7 510(k) clearances. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 31 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 6 of them its own earlier devices. 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 Motus GI Medical Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Motus GI Medical Technologies, Ltd.’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) Report