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
K910089Unknown

Mega Lumbar Puncture Kit

Megadyne Medical Products, Inc, Tampa FL / Traditional, Unknown
FDA source (opens on fda.gov)

K910089 is the FDA 510(k) clearance record for MEGA LUMBAR PUNCTURE KIT, a class II device, cleared for Megadyne Medical Products, Inc. on under FDA product code FMJ (Manometer, Spinal-Fluid). FDA records list 50 510(k) clearances for Megadyne Medical Products, Inc., from to . As of , FDA records show no recalls naming K910089.

Clearance record

Decision date
Received
(162 days to decision)
Product code
FMJ Manometer, Spinal-Fluid
Regulation
21 CFR 880.2500
Device class
Class II
Review panel
General Hospital
Applicant
Megadyne Medical Products, Inc. P.O.Box 260956, Tampa FL
Third party review
No

Clearances, product code FMJ

Trailing 12 months

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

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