Multigon Industries, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Multigon Industries, Inc.” (first 1985, latest 2005), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 118 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HGL | Transducer, Ultrasonic, Obstetric | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
Review panels
- Obstetrics and Gynecology (3)
- Radiology (3)
- Cardiovascular (2)
Most recent Multigon Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | JAF | 2005-08-29 | 28 |
| K051739 | POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. | IYN | 2005-07-28 | 30 |
| K912044 | MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR | HIF | 1991-06-24 | 47 |
| K881263 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER | HGL | 1990-01-05 | 652 |
| K882755 | MODEL 500V VASCULAR SPECTRUM ANALYZER | IYN | 1988-11-29 | 147 |
| K863589 | MODEL 600 VASCULAR DUPLEX IMAGER | DXK | 1987-06-24 | 282 |
| K860435 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER | DPT | 1986-05-05 | 90 |
| K852680 | TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG | HET | 1985-12-23 | 181 |
Recalls
openFDA lists no recalls under a recalling firm named Multigon Industries, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Multigon Industries, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Multigon Industries, Inc.” (first 1985, latest 2005), across 7 product codes in 3 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 Multigon Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Multigon Industries, Inc. is 118 days.
Which FDA product codes appear under Multigon Industries, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2); DPT (Probe, Blood-Flow, Extravascular, 1); DXK (Echocardiograph, 1).
Next steps
- See all 8 Multigon Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Multigon Industries, 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.