Genicon, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Genicon, Inc.” (first 2004, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 65 days. Since 2017 the median was 42 days, against 107 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 317 |
| 2015 | 0 | — |
| 2016 | 1 | 65 |
| 2017 | 1 | 126 |
| 2018 | 3 | 19 |
| 2019 | 1 | 42 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Genicon, Inc. took a median 42 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| FZP | Clip, Implantable | 1 | 1 |
Review panels
Most recent Genicon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190168 | Aquas Probes | GEI | 2019-03-14 | 42 |
| K181791 | SIMPLYSTRONG, SIMPLYEZEE | GCJ | 2018-08-21 | 47 |
| K180836 | Genistrong | GCJ | 2018-04-18 | 19 |
| K180579 | Ezee Retrieval | GCJ | 2018-03-19 | 14 |
| K171752 | X-SURGE | GEI | 2017-10-17 | 126 |
| K162059 | EZEE RETRIEVAL | GCJ | 2016-09-29 | 65 |
| K132375 | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG | GCJ | 2014-06-12 | 317 |
| K100090 | IMPLANTABLE CLIP | FZP | 2010-02-02 | 21 |
| K061417 | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 | GEI | 2006-10-10 | 141 |
| K041967 | GENICON SUCTION IRRIGATION SYSTEM | GCJ | 2004-11-12 | 114 |
1 earlier clearances. See the full list in Caduvo.
Recalls
18 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2020-09-17.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Genicon, Inc. (6)
- Genicon (5)
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.
- Genicon, LC (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genicon, Inc.?
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Genicon, Inc.” (first 2004, latest 2019), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genicon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genicon, Inc. is 65 days. Since 2017: 42 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Genicon, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); FZP (Clip, Implantable, 1).
Next steps
- See all 11 Genicon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Genicon, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.