Gyrus Acmi, Inc.
Gyrus Acmi, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2026, with 11 FDA device recalls on record.
Top product codes for Gyrus Acmi, Inc.
FDA recalls by Gyrus Acmi, Inc.
10 most recent of 11- Z-1185-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
- Z-1186-2019 — Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
- Z-1182-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
- Z-1184-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
- Z-1178-2019 — Olympus Diego Elite Console MDCONS 100
- Z-1179-2019 — Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
- Z-1180-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
- Z-1183-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
- Z-1187-2019 — Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
- Z-1181-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
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 Acmi, Inc.
- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more
- K231327 — POWERSEAL Sealer and Divider
- K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K212650 — Celeris, Disposable Sinus Debrider
- K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
- K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K181696 — ChitoZolve
- K180086 — Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
- K170908 — PK AIM
- K163373 — PK AIM
- K161038 — PK Morcellator
- K161825 — PK AIM
- K152744 — DIEGO ELITE DRILL
- K152531 — InstaClear Lens Cleaner
- K152219 — PK AIM
- K142759 — PK Cutting Forceps for ESG-400 Workstation
- K142350 — PK J-HOOK
- K142289 — PK Spatula
- K142154 — PK NEEDLE
- K132383 — GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
- K123429 — OLYMPUS ENERGY POWER SYSTEM (EPS)
- K122605 — PKS BILL
- K121678 — DTAD
- K120474 — GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
- K120567 — GYRUS AMCI PK BUTTON ELECTRODE
- K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
- K110852 — DOLPHIN 3 FLUID MANAGEMENT SYSTEM
- K102970 — GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
- K092571 — GYRUS ACMI BIOCOAG PROBE
- K100816 — PK SUPERPULSE SYSEM GENERATOR MODEL 744000
- K100896 — GYRUS ACMI HALO PKS CUTTING FORCEPS
- K093181 — GYRUS ACMI PK BUTTON ELECTRODE
- K092682 — GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
- K092278 — GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
- K080844 — G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
- K090814 — MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
- K083013 — PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
- K082054 — GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003
- K081954 — GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
- K080093 — PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
- K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.