Medicon Instruments, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medicon Instruments, Inc.” (first 1994, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 162 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 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| DRC | Trocar | 1 | 1 |
Review panels
Most recent Medicon Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K936249 | MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES | GEI | 1994-07-21 | 203 |
| K936246 | MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES | GEI | 1994-07-21 | 203 |
| K936262 | DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS | GCJ | 1994-07-01 | 183 |
| K936247 | MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | DRC | 1994-05-19 | 140 |
| K936248 | MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS | GCJ | 1994-05-16 | 137 |
| K936250 | RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP | GCJ | 1994-05-12 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Medicon Instruments, Inc..
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.
- Medicon EG (17 510(k)s)
- Medicon, Inc. (15 510(k)s)
- Medicon Hellas S.A (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicon Instruments, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Medicon Instruments, Inc.” (first 1994, latest 1994), across 3 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 Medicon Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicon Instruments, Inc. is 162 days.
Which FDA product codes appear under Medicon Instruments, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); DRC (Trocar, 1).
Next steps
- See all 6 Medicon Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Medicon Instruments, 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.