510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231960Substantially Equivalent

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether

Anx Robotica Corp., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231960 is the FDA 510(k) clearance record for NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether, a class II device, cleared for Anx Robotica Corporation on under FDA product code QKZ (Magnetically Maneuvered Capsule Endoscopy System). FDA's definition for product code QKZ reads: "A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures...". FDA records list 10 510(k) clearances for Anx Robotica Corporation, from to . As of , FDA records show no recalls naming K231960.

Clearance record

Decision date
Received
(92 days to decision)
Product code
QKZ Magnetically Maneuvered Capsule Endoscopy System
Regulation
21 CFR 876.1310
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Anx Robotica Corporation 6010 W Spring Creek Pkwy., Plano TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QKZ

Trailing 12 months

FDA records hold no clearances under product code QKZ in the trailing twelve months.

FDA records show no clearances under product code QKZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260