Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K003914Substantially Equivalent

Medtronic Ps Medical Neuropen Endoscope and Optical Accessories

Medtronic PS Medical, Goleta CA / Abbreviated, Substantially Equivalent

K003914 is the FDA 510(k) clearance record for MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES, a class II device, cleared for Medtronic PS Medical on under FDA product code GWG (Endoscope, Neurological). FDA's definition for product code GWG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 14 510(k) clearances for Medtronic PS Medical, from to . As of , FDA records show no recalls naming K003914.

Clearance record

Decision date
Received
(65 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Medtronic PS Medical 125 Cremona Dr., Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code GWG

Trailing 12 months
2 clearances under product code GWG in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260