Gyrus Medical, Inc
FDA Regulatory Profile
Gyrus Medical, Inc appears in FDA public data with 4 recalls, 23 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0100-2015, Class II) was initiated on August 27, 2014. Its most recent 510(k) clearance was granted on November 9, 2005.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 23
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0100-2015 | Class II | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm | August 27, 2014 |
| Z-2269-2014 | Class II | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device | July 8, 2014 |
| Z-1196-2014 | Class II | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 m | February 19, 2014 |
| Z-1983-2013 | Class II | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI | July 24, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | November 9, 2005 |
| K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES | October 25, 2005 |
| K041999 | GYRUS PLASMA SKIN RESURFACING SYSTEM | March 2, 2005 |
| K041633 | GYRUS PLASMACISION LAPAROSCOPIC SPATULA | October 22, 2004 |
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | September 10, 2004 |
| K024286 | GYRUS OPEN FORCEPS | November 17, 2003 |
| K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) | July 21, 2003 |
| K031081 | EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS | May 21, 2003 |
| K031079 | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE | May 21, 2003 |
| K031082 | EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK | May 21, 2003 |
| K031078 | EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS | May 16, 2003 |
| K031080 | EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS | May 16, 2003 |
| K023111 | GYRUS PLASMA SKIN RESURFACING SYSTEM | March 13, 2003 |
| K023492 | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS | November 13, 2002 |
| K023493 | PK ZIP WING CUTTING DISSECTOR | November 13, 2002 |
| K020585 | ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT | July 13, 2002 |
| K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM | December 19, 2000 |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | April 28, 2000 |
| K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | December 27, 1999 |
| K993749 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | December 3, 1999 |