510(k) Report

FDA applicant

Asensus Surgical, Inc.

Durham, NC6 decisions2021–20261 recall

FDA records 6 decisions for Asensus Surgical, Inc. (Durham, NC) from 2021 to 2026: 6 510(k) clearances. All are in product code NAY (System, Surgical, Computer Controlled Instrument). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 75 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Asensus Surgical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Asensus Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 22022: 12023: 12024: 12026 (partial year): 1
2021high 2 (2021) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1, 1 Class I
2021high 1 (2023) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Asensus Surgical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Asensus Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NAYSystem, Surgical, Computer Controlled Instrument6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 75 days; 0 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220889Senhance Surgical SystemAsensus Surgical, Inc. · 20221cites it
  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 20231cites it
  • K212054Senhance Surgical SystemAsensus Surgical, Inc. · 20211cites it

What has FDA decided for it lately?

  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K233866Senhance Surgical SystemAsensus Surgical, Inc. · 2024
  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 20231 Class I recall
  • K220889Senhance Surgical SystemAsensus Surgical, Inc. · 2022
  • K212054Senhance Surgical SystemAsensus Surgical, Inc. · 2021
  • K211325Senhance Surgical SystemAsensus Surgical, Inc. · 2021

All 5 as Asensus Surgical, Inc. →The one decision as Asensus Surgical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K223095Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog…Sep 15, 2023Class I