Chrysalis Intelligence · Sponsors · Asensus Surgical, Inc.

Asensus Surgical, Inc.

Durham, NC, US · 6 510(k) clearances · 1 recalls (1 Class I)

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Total clearances
6
2021-07-27 → 2026-05-12
Last 12 months
1
Product codes
1
Most recent
2026-05-12
Name variants in FDA filings: Asensus Surgical, Inc. / Asensus Surgical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NAY System, Surgical, Computer Controlled Instrument Class II Gastroenterology, Urology 6 2026-05-12
Safety

Recalls (1)

Class I (serious)
1
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2023-09-15
DateSeverityStatusRecall # ProductCodeReason
2023-09-15 Class I Terminated Z-0170-2024 Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur… — Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm m…
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-05-12 K254192 Senhance Ultrasonic System NAY Class II Gastroenterology, Urology
2024-07-19 K233866 Senhance Surgical System NAY Class II Gastroenterology, Urology
2023-03-16 K223095 Senhance Surgical System NAY Class II Gastroenterology, Urology
2022-05-27 K220889 Senhance Surgical System NAY Class II Gastroenterology, Urology
2021-08-30 K212054 Senhance Surgical System NAY Class II Gastroenterology, Urology
2021-07-27 K211325 Senhance Surgical System NAY Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence