Gyrus ACMI, Inc.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 43
- Inspections
- 20
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1179-2019 | Class II | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA | March 8, 2019 |
| Z-1184-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS | March 8, 2019 |
| Z-1185-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC | March 8, 2019 |
| Z-1178-2019 | Class II | Olympus Diego Elite Console MDCONS 100 | March 8, 2019 |
| Z-1180-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS | March 8, 2019 |
| Z-1183-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC | March 8, 2019 |
| Z-1187-2019 | Class II | Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS | March 8, 2019 |
| Z-1182-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS | March 8, 2019 |
| Z-1186-2019 | Class II | Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS | March 8, 2019 |
| Z-1181-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC | March 8, 2019 |
| Z-1337-2018 | Class II | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system | August 3, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | March 2, 2026 |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureterosc | March 25, 2024 |
| K231327 | POWERSEAL Sealer and Divider | October 25, 2023 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, | January 27, 2023 |
| K212650 | Celeris, Disposable Sinus Debrider | January 19, 2022 |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | January 4, 2022 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Lase | June 3, 2021 |
| K181696 | ChitoZolve | November 30, 2018 |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | March 8, 2018 |
| K171440 | Berkeley VC-10 Vacuum Curettage System | September 29, 2017 |
| K170908 | PK AIM | May 19, 2017 |
| K163373 | PK AIM | December 12, 2016 |
| K161038 | PK Morcellator | October 7, 2016 |
| K161825 | PK AIM | September 26, 2016 |
| K152744 | DIEGO ELITE DRILL | June 10, 2016 |
| K152531 | InstaClear Lens Cleaner | January 15, 2016 |
| K152219 | PK AIM | December 17, 2015 |
| K142759 | PK Cutting Forceps for ESG-400 Workstation | January 13, 2015 |
| K142350 | PK J-HOOK | January 8, 2015 |
| K142289 | PK Spatula | December 31, 2014 |