510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833822Substantially Equivalent

P-S Medical Csf Access Dev 15Mm/25mm

Pudenz-Schulte Medical Research Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833822 is the FDA 510(k) clearance record for P-S MEDICAL CSF ACCESS DEV 15MM/25MM, a class II device, cleared for Pudenz-Schulte Medical Research Corp. on under FDA product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular). FDA records list 40 510(k) clearances for Pudenz-Schulte Medical Research Corp., from to . As of , FDA records show no recalls naming K833822.

Clearance record

Decision date
Received
(205 days to decision)
Product code
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Pudenz-Schulte Medical Research Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LKG

Trailing 12 months

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

FDA records show no clearances under product code LKG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKG, 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