510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915546Substantially Equivalent

Ps Medical Ventriculostomy Kit

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

K915546 is the FDA 510(k) clearance record for PS MEDICAL VENTRICULOSTOMY KIT, a class II device, cleared for Pudenz-Schulte Medical Research Corp. on under FDA product code HBG (Drills, Burrs, Trephines & Accessories (Manual)). FDA records list 40 510(k) clearances for Pudenz-Schulte Medical Research Corp., from to . As of , FDA records show one recall naming K915546.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HBG Drills, Burrs, Trephines & Accessories (Manual)
Regulation
21 CFR 882.4300
Device class
Class II
Review panel
Neurology
Applicant
Pudenz-Schulte Medical Research Corp. P.O. Box 2090, Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code HBG

Trailing 12 months
1 clearance under product code HBG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260