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510(k) K910089

MEGA LUMBAR PUNCTURE KIT by Megadyne Medical Products, Inc. — Product Code FMJ

K910089 is an FDA 510(k) premarket notification submitted by Megadyne Medical Products, Inc. for the device "MEGA LUMBAR PUNCTURE KIT". The FDA issued a decision of Substantially Equivalent (kit) on June 20, 1991. The device falls under product code FMJ (Manometer, Spinal-Fluid), a Class II device regulated under 21 CFR 880.2500. Megadyne Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 20, 1991
Date Received
January 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Spinal-Fluid
Device Class
Class II
Regulation Number
880.2500
Review Panel
HO
Submission Type

Other clearances by Megadyne Medical Products, Inc.

  • K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Pa (July 12, 2024)
  • K213696 — ETHICON Megadyne Electrosurgical Generator (January 21, 2022)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (March 24, 2020)
  • K191328 — Megadyne Foot Switch (July 26, 2019)
  • K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA F (February 18, 2015)
  • K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE (January 24, 2014)
  • K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (December 16, 2008)
  • K081791 — E-Z CLEAN ELECTROSURGICAL ELECTRODE (October 21, 2008)
  • K072559 — SUCTION COAGULATOR (October 5, 2007)

Other clearances for product code FMJ

  • K170305 — Spinal Manometer NRFit; Spinal Manometer LUER (July 25, 2017)
  • K032432 — BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (August 28, 2003)
  • K970287 — LUMBAR PUNCTURE KIT (April 7, 1997)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K882405 — HYPODERMIC NEEDLE SHEATH HOLDER (June 29, 1988)

FDA data resources