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510(k) K910366

MEGA GENERAL PURPOSE INSTRUMENT KIT by Megadyne Medical Products, Inc. — Product Code KDD

K910366 is an FDA 510(k) premarket notification submitted by Megadyne Medical Products, Inc. for the device "MEGA GENERAL PURPOSE INSTRUMENT KIT". The FDA issued a decision of Substantially Equivalent on March 28, 1991. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Megadyne Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1991
Date Received
January 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources