510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954116Substantially Equivalent

Silicone Malecot Catheter with Pezzer/mushroom Tip

Technical Products, Inc., Decatur GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954116 is the FDA 510(k) clearance record for SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP, a class II device, cleared for Technical Products, Inc. on under FDA product code FEW (Catheter, Malecot). FDA records list 6 510(k) clearances for Technical Products, Inc., from to . As of , FDA records show no recalls naming K954116.

Clearance record

Decision date
Received
(109 days to decision)
Product code
FEW Catheter, Malecot
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Technical Products, Inc. 2416 Park Central Blvd., Decatur GA
510(k) summary
Statement
Third party review
No

Clearances, product code FEW

Trailing 12 months

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

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