Company ยท US
Gyrus Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2005. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2005 | K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR Gyrus Medical, Inc. | GEI |
| Oct 25, 2005 | K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES Gyrus Medical, Inc. | GEI |
| Mar 2, 2005 | K041999 | GYRUS PLASMA SKIN RESURFACING SYSTEM Gyrus Medical, Inc. | GEI |
| Oct 22, 2004 | K041633 | GYRUS PLASMACISION LAPAROSCOPIC SPATULA Gyrus Medical, Inc. | GEI |
| Sep 10, 2004 | K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) Gyrus Medical , Ltd., GB | GEI |
| Nov 17, 2003 | K024286 | GYRUS OPEN FORCEPS Gyrus Medical, Inc. | GEI |
| Jul 21, 2003 | K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) Gyrus Medical, Inc. | GEI |
| May 21, 2003 | K031082 | EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK Gyrus Medical, Inc. | GEI |
| May 21, 2003 | K031081 | EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS Gyrus Medical, Inc. | GEI |
| May 21, 2003 | K031079 | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE Gyrus Medical, Inc. | GEI |
| May 16, 2003 | K031080 | EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS Gyrus Medical, Inc. | GEI |
| May 16, 2003 | K031078 | EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS Gyrus Medical, Inc. | GEI |
| Mar 13, 2003 | K023111 | GYRUS PLASMA SKIN RESURFACING SYSTEM Gyrus Medical, Inc. | GEI |
| Nov 13, 2002 | K023493 | PK ZIP WING CUTTING DISSECTOR Gyrus Medical, Inc. | GEI |
| Nov 13, 2002 | K023492 | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS Gyrus Medical, Inc. | GEI |
| Jul 13, 2002 | K020585 | ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT Gyrus Medical, Inc. | GEI |
| Dec 19, 2000 | K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM Gyrus Medical , Ltd., GB | KNS |
| Apr 28, 2000 | K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE Gyrus Medical , Ltd., GB | FJL |
| Dec 27, 1999 | K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE Gyrus Medical , Ltd., GB | KNS |
| Dec 3, 1999 | K993749 | GYRUS HYSTEROSCOPIC RESECTOSCOPE Gyrus Medical , Ltd., GB | HIH |
| Jun 29, 1999 | K990628 | GYRUS ENDOUROLOGY SYSTEM Gyrus Medical , Ltd., GB | KNS |
| Jan 21, 1999 | K982771 | GYRUS HYSTEROSCOPIC RESECTOSCOPE Gyrus Medical , Ltd., GB | HIH |
| May 1, 1990 | K891681 | DILECTRON URINARY CONDUCTIVITY PROBE Gyrus Medical , Ltd., GB | JRE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2014 | Gyrus Medical, Inc GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm
REF 3345PK - PKS MOLly Forceps 5mm/45cm
REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm
REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm
REF 3 Terminated |
GEI | K031078 K031081 |
| Aug 19, 2014 | Gyrus Medical, Inc Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB Terminated |
KNH | None listed |
| Mar 13, 2014 | Gyrus Medical, Inc Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only.
The disposable Falope-Ring Band Applicator is Terminated |
KNH | None listed |
| Aug 19, 2013 | Gyrus Medical, Inc GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO.
GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO.
The Dissectors are Terminated |
GEI | K031080 |
| Jun 27, 2006 | Gyrus Medical, Inc. GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or Terminated |
GEI | K020585 |
| Jul 20, 2004 | Gyrus Medical, Inc Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Terminated |
GEI | None listed |