Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Asensus Surgical with 6 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 12, 2026: Senhance Ultrasonic System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 12, 2026 | Senhance Ultrasonic SystemK254192 · NAY | 510(k) clearances |
| Jul 19, 2024 | Senhance Surgical SystemK233866 · NAY | 510(k) clearances |
| Sep 15, 2023 | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Class I · Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issu | Device recalls |
| Mar 16, 2023 | Senhance Surgical SystemK223095 · NAY | 510(k) clearances |
| May 27, 2022 | Senhance Surgical SystemK220889 · NAY | 510(k) clearances |
| Aug 30, 2021 | Senhance Surgical SystemK212054 · NAY | 510(k) clearances |
| Jul 27, 2021 | Senhance Surgical SystemK211325 · NAY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
