Gyrus Medical, Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
23
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0100-2015Class IIGYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cmAugust 27, 2014
Z-2269-2014Class IIGyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device July 8, 2014
Z-1196-2014Class IIGyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mFebruary 19, 2014
Z-1983-2013Class IIGYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMIJuly 24, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K050550GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATORNovember 9, 2005
K050460GYRUS PLASMACISION AND PLASMABLEND ELECTRODESOctober 25, 2005
K041999GYRUS PLASMA SKIN RESURFACING SYSTEMMarch 2, 2005
K041633GYRUS PLASMACISION LAPAROSCOPIC SPATULAOctober 22, 2004
K041285GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)September 10, 2004
K024286GYRUS OPEN FORCEPSNovember 17, 2003
K031085GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)July 21, 2003
K031079EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODEMay 21, 2003
K031082EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOKMay 21, 2003
K031081EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORSMay 21, 2003
K031078EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPSMay 16, 2003
K031080EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPSMay 16, 2003
K023111GYRUS PLASMA SKIN RESURFACING SYSTEMMarch 13, 2003
K023492EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPSNovember 13, 2002
K023493PK ZIP WING CUTTING DISSECTORNovember 13, 2002
K020585ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUTJuly 13, 2002
K003569PLASMAKINETIC ENDOUROLOGY SYSTEMDecember 19, 2000
K001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEApril 28, 2000
K994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODEDecember 27, 1999
K993749GYRUS HYSTEROSCOPIC RESECTOSCOPEDecember 3, 1999