Genicon, LC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Genicon, LC” (first 1999, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 119 days. 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 | 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| FZP | Clip, Implantable | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
Most recent Genicon, LC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030174 | GENICON LAPAROSCOPES | GCJ | 2003-06-19 | 153 |
| K030269 | GENICON CLIP APPLIER | FZP | 2003-03-20 | 52 |
| K002542 | REUSABLE CANNULA | GCJ | 2000-10-23 | 68 |
| K993625 | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | HIF | 2000-06-20 | 238 |
| K991382 | SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 | GCJ | 1999-07-15 | 85 |
| K982472 | GENICON TROCAR | GEA | 1999-02-04 | 204 |
Recalls
openFDA lists no recalls under a recalling firm named Genicon, LC.
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.
- Genicon, Inc. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genicon, LC?
FDA lists 6 510(k) clearances under the applicant name “Genicon, LC” (first 1999, latest 2003), across 4 product codes in 2 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 Genicon, LC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genicon, LC is 119 days.
Which FDA product codes appear under Genicon, LC?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); FZP (Clip, Implantable, 1); GEA (Cannula, Surgical, General & Plastic Surgery, 1).
Next steps
- See all 6 Genicon, LC clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Genicon, LC'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.