Gyrus Acmi, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Gyrus Acmi, Inc.” (first 2007, latest 2026), plus 2 PMA decisions, across 19 product codes in 6 review panels. Median 510(k) review time under this name: 132 days. Since 2017 the median was 149 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Olympus, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 107 |
| 2013 | 1 | 149 |
| 2014 | 3 | 135 |
| 2015 | 3 | 132 |
| 2016 | 5 | 134 |
| 2017 | 2 | 94 |
| 2018 | 2 | 106 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 28 |
| 2022 | 2 | 88 |
| 2023 | 2 | 218 |
| 2024 | 1 | 178 |
| 2025 | 0 | — |
| 2026 | 1 | 207 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gyrus Acmi, Inc. took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 20 | 20 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FGA | Kit, Nephroscope | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
Plus 9 more product codes.
Review panels
- General and Plastic Surgery (22)
- Gastroenterology and Urology (8)
- Obstetrics and Gynecology (6)
- Ear, Nose and Throat (5)
- General Hospital (3)
- Anesthesiology (1)
Most recent Gyrus Acmi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | GEI | 2026-03-02 | 207 |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | FGB | 2024-03-25 | 178 |
| K231327 | POWERSEAL Sealer and Divider | GEI | 2023-10-25 | 170 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | GEX | 2023-01-27 | 267 |
| K212650 | Celeris, Disposable Sinus Debrider | ERL | 2022-01-19 | 149 |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | GEI | 2022-01-04 | 27 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | 2021-06-03 | 28 |
| K181696 | ChitoZolve | LYA | 2018-11-30 | 156 |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | FGE | 2018-03-08 | 55 |
| K171440 | Berkeley VC-10 Vacuum Curettage System | HHI | 2017-09-29 | 136 |
33 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180007 | PMA | Spiration® Valve System | 2018-12-03 |
| P870076 | PMA | FALOPE RING BAND AND APPLICATOR SYSTEMS | 1993-09-29 |
Recalls
24 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2019-03-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gyrus Ent LLC (28 510(k)s)
- Gyrus Medical, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gyrus Acmi, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Gyrus Acmi, Inc.” (first 2007, latest 2026), plus 2 PMA decisions, across 19 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gyrus Acmi, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gyrus Acmi, Inc. is 132 days. Since 2017: 149 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gyrus Acmi, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 20); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3).
Next steps
- See all 43 Gyrus Acmi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Gyrus Acmi, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.