FDA 510(k) clearance · back to tracker

ActivSight Intraoperative Imaging System

Activ Surgical, Inc. cleared K231344 on 2023-08-02, decision: substantially equivalent

K-number

K231344

Sponsor

Activ Surgical, Inc.

Device

ActivSight Intraoperative Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-08-02

Product code

OWN

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K231344on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.