Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gyrus Acmi, Inc. — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
226 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Actio | Gyrus Acmi, Inc. | 2026-03-02 | 207 | 0 |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) | Gyrus Acmi, Inc. | 2024-03-25 | 178 | 0 |
| K231327 | POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. | 2023-10-25 | 170 | 0 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed L | Gyrus Acmi, Inc. | 2023-01-27 | 267 | 8 |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022-01-19 | 149 | 0 |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatul | Gyrus Acmi, Inc. | 2022-01-04 | 27 | 0 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE | Gyrus Acmi, Inc. | 2021-06-03 | 28 | 0 |
| K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018-11-30 | 156 | 0 |
| K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | Gyrus Acmi, Inc. | 2018-03-08 | 55 | 13 |
| K170908 | PK AIM | Gyrus Acmi, Inc. | 2017-05-19 | 52 | 0 |
| K163373 | PK AIM | Gyrus Acmi, Inc. | 2016-12-12 | 11 | 0 |
| K161038 | PK Morcellator | Gyrus Acmi, Inc. | 2016-10-07 | 177 | 0 |
| K161825 | PK AIM | Gyrus Acmi, Inc. | 2016-09-26 | 87 | 0 |
| K152744 | DIEGO ELITE DRILL | Gyrus Acmi, Inc. | 2016-06-10 | 261 | 0 |
| K152531 | InstaClear Lens Cleaner | Gyrus Acmi, Inc. | 2016-01-15 | 134 | 2 |
| K152219 | PK AIM | Gyrus Acmi, Inc. | 2015-12-17 | 132 | 0 |
| K142759 | PK Cutting Forceps for ESG-400 Workstation | Gyrus Acmi, Inc. | 2015-01-13 | 110 | 0 |
| K142350 | PK J-HOOK | Gyrus Acmi, Inc. | 2015-01-08 | 139 | 1 |
| K142289 | PK Spatula | Gyrus Acmi, Inc. | 2014-12-31 | 135 | 0 |
| K142154 | PK NEEDLE | Gyrus Acmi, Inc. | 2014-12-19 | 135 | 0 |
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CA | Gyrus Acmi, Inc. | 2014-02-04 | 188 | 1 |
| K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) | Gyrus Acmi, Inc. | 2013-04-05 | 149 | 2 |
| K122605 | PKS BILL | Gyrus Acmi, Inc. | 2012-12-05 | 100 | 0 |
| K121678 | DTAD | Gyrus Acmi, Inc. | 2012-08-30 | 84 | 0 |
| K120474 | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY | Gyrus Acmi, Inc. | 2012-07-10 | 145 | 0 |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2012-06-20 | 114 | 0 |
| K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | Gyrus Acmi, Inc. | 2011-09-01 | 136 | 0 |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | 2011-07-19 | 113 | 0 |
| K102970 | GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT | Gyrus Acmi, Inc. | 2011-05-20 | 226 | 0 |
| K092571 | GYRUS ACMI BIOCOAG PROBE | Gyrus Acmi, Inc. | 2010-10-20 | 425 | 0 |
| K100816 | PK SUPERPULSE SYSEM GENERATOR MODEL 744000 | Gyrus Acmi, Inc. | 2010-07-01 | 100 | 0 |
| K100896 | GYRUS ACMI HALO PKS CUTTING FORCEPS | Gyrus Acmi, Inc. | 2010-06-17 | 78 | 1 |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2010-02-24 | 139 | 0 |
| K092682 | GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS | Gyrus Acmi, Inc. | 2009-12-11 | 101 | 0 |
| K092278 | GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 | Gyrus Acmi, Inc. | 2009-09-29 | 63 | 0 |
| K080844 | G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE | Gyrus Acmi, Inc. | 2009-08-13 | 505 | 0 |
| K090814 | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND | Gyrus Acmi, Inc. | 2009-04-20 | 26 | 0 |
| K083013 | PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO T | Gyrus Acmi, Inc. | 2008-12-09 | 61 | 0 |
| K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 74400 | Gyrus Acmi, Inc. | 2008-08-06 | 16 | 0 |
| K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL | Gyrus Acmi, Inc. | 2008-07-31 | 22 | 0 |
| K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK | Gyrus Acmi, Inc. | 2008-05-02 | 109 | 0 |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE | Gyrus Acmi, Inc. | 2007-12-13 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda