510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K911382Substantially Equivalent

Ipi Algo-Line Catheter

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

K911382 is the FDA 510(k) clearance record for IPI ALGO-LINE CATHETER, a class II device, cleared for Pudenz-Schulte Medical Research Corp. on under FDA product code MAJ (Catheter, Percutaneous, Intraspinal, Short Term). FDA records list 40 510(k) clearances for Pudenz-Schulte Medical Research Corp., from to . As of , FDA records show no recalls naming K911382.

Clearance record

Decision date
Received
(112 days to decision)
Product code
MAJ Catheter, Percutaneous, Intraspinal, Short Term
Regulation
21 CFR 868.5120
Device class
Class II
Review panel
Anesthesiology
Applicant
Pudenz-Schulte Medical Research Corp. P.O. Box 2090, Goleta CA
Third party review
No

Clearances, product code MAJ

Trailing 12 months

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

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