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Asensus Surgical, Inc.

File for FDA 510(k) clearance for the next generation ISU features

Delivered after the deadline

AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.

Announced
6 Jan 2021
Due
30 Jun 2021
Delivered
August 2021
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“File for FDA 510(k) clearance for the next generation ISU features”

What we found

Evidence strength A What the grades mean

The company received FDA clearance for the ISU features in August 2021, which occurred after the first-half 2021 deadline.

  • A
    Transenterix, Inc. 10-K filed 2022-02-28 Regulatory filing · published 28 Feb 2022 · retrieved 24 Oct 2026 · kept permanently by the SEC · fingerprint be1f1bc5053d
    “in August 2021, we received FDA clearance for expanded augmented intelligence features on the ISU.” ✓ confirmed on the page

Checked 24 Oct 2026.

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type
Regulatory other
Indicative materiality
Medium rules
Action
File
Deliverable
FDA 510(k) clearance application for next generation ISU features
Where
United States
In the company’s control
High
Specificity
High
Depends on
Regulatory

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
  3. Second check: disagreesClaude (Anthropic) re-read the evidence blind and read it as “no_evidence”.
  4. Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the second check.

Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works

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Report an error in this entry Reference: KI-C-2021-C876378-021156 · Corrections policy

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