Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K940096Substantially Equivalent

Ps Medical Catheter Placement Kit

Pudenz-Schulte Medical Research Corp., Goleta CA / Traditional, Substantially Equivalent

K940096 is the FDA 510(k) clearance record for PS MEDICAL CATHETER PLACEMENT KIT, a class II device, cleared for Pudenz-Schulte Medical Research Corp. 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 40 510(k) clearances for Pudenz-Schulte Medical Research Corp., from to . As of , FDA records show no recalls naming K940096.

Clearance record

Decision date
Received
(116 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Pudenz-Schulte Medical Research Corp. University Business Center, Goleta CA
510(k) summary
Statement
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