Gyrus Medical, Inc.
Gyrus Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2005, with 4 FDA device recalls on record.
Top product codes for Gyrus Medical, Inc.
FDA recalls by Gyrus Medical, Inc.
- Z-0100-2015 — 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 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
- Z-2269-2014 — 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-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.
- Z-1196-2014 — 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 a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
- Z-1983-2013 — 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 sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Gyrus Medical, Inc.
- K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
- K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
- K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM
- K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA
- K024286 — GYRUS OPEN FORCEPS
- K031085 — GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
- K031079 — EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
- K031081 — EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
- K031082 — EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK
- K031078 — EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
- K031080 — EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS
- K023111 — GYRUS PLASMA SKIN RESURFACING SYSTEM
- K023492 — EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS
- K023493 — PK ZIP WING CUTTING DISSECTOR
- K020585 — ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
Data sourced from openFDA. This site is unofficial and independent of the FDA.