ClearanceBrief
510(k) K031285 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD

ApplicantMegadyne Medical Products, Inc., Cincinnati OH, US
DecisionSubstantially Equivalent, May 19, 2003
ReceivedApr 23, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031285

DateFirm and productCodeLinked 510(k)
Jul 3, 2024Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Produ
Open, Classified
GEINone listed
Jun 30, 2023Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
Open, Classified
GEINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.