510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242163Substantially Equivalent

SmartSurgN Visualization System

SmartsurgN, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242163 is the FDA 510(k) clearance record for SmartSurgN Visualization System, a class II device, cleared for SmartsurgN, Inc. on under FDA product code OWN (Confocal Optical Imaging). FDA's definition for product code OWN reads: "Collection of light signals for visualization of cellular microstructures". FDA records list 2 510(k) clearances for SmartsurgN, Inc., from to . As of , FDA records show no recalls naming K242163.

Clearance record

Decision date
Received
(635 days to decision)
Product code
OWN Confocal Optical Imaging
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
SmartsurgN, Inc. 1038 Leigh Ave. Suite 101b, San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWN

Trailing 12 months
8 clearances under product code OWN in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWN, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20264
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260