510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981258Substantially Equivalent

Manan Malecot Basket Drainage Catheter

Medical Device Technologies, Inc., Gainsville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981258 is the FDA 510(k) clearance record for MANAN MALECOT BASKET DRAINAGE CATHETER, a class II device, cleared for Medical Device Technologies, Inc. on under FDA product code FEW (Catheter, Malecot). FDA records list 46 510(k) clearances for Medical Device Technologies, Inc., from to . As of , FDA records show no recalls naming K981258.

Clearance record

Decision date
Received
(16 days to decision)
Product code
FEW Catheter, Malecot
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Device Technologies, Inc. 4445 SW 35th Ter., Gainsville FL
510(k) summary
Summary
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