Company ยท US
Asensus Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2026 | K254192 | Senhance Ultrasonic System Asensus Surgical | NAY |
| Jul 19, 2024 | K233866 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Mar 16, 2023 | K223095 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| May 27, 2022 | K220889 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Aug 30, 2021 | K212054 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Jul 27, 2021 | K211325 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2023 | Asensus Surgical Inc Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Nu Terminated |
NAY | K223095 |