Gyrus Ent LLC: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Gyrus Ent LLC” (first 1997, latest 2004), across 12 product codes in 4 review panels. Median 510(k) review time under this name: 56 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 4 | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 3 | 3 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| EQJ | Bur, Ear, Nose And Throat | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Gyrus Ent LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | NIX | 2004-08-20 | 126 |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | ERL | 2004-03-03 | 70 |
| K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM | GEI | 2004-02-05 | 129 |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | ETB | 2003-11-24 | 12 |
| K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | HAW | 2003-05-02 | 88 |
| K021595 | GYRUS ENT NERVE STIMULATOR | ETN | 2002-10-24 | 162 |
| K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | GEI | 2002-08-26 | 88 |
| K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 | GEI | 2002-05-28 | 78 |
| K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | GEI | 2002-04-04 | 85 |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | ERL | 2002-03-08 | 14 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gyrus Ent LLC.
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 Acmi, Inc. (43 510(k)s)
- Gyrus Medical, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gyrus Ent LLC?
FDA lists 28 510(k) clearances under the applicant name “Gyrus Ent LLC” (first 1997, latest 2004), across 12 product codes in 4 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 Ent LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gyrus Ent LLC is 56 days.
Which FDA product codes appear under Gyrus Ent LLC?
The most frequent FDA product codes under this applicant name are ETB (Prosthesis, Partial Ossicular Replacement, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 4).
Next steps
- See all 28 Gyrus Ent LLC clearances with predicates and recalls
- Run predicate analysis for product code ETB, Gyrus Ent LLC'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.