Marina Medical Instruments, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Marina Medical Instruments, Inc.” (first 2001, latest 2005), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 194 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 |
|---|---|---|---|
| GDW | Staple, Implantable | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| HHW | Pessary, Vaginal | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Review panels
Most recent Marina Medical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042534 | MARINA MEDICAL FINGER PROTECTORS | KGO | 2005-05-10 | 235 |
| K031463 | MARINA MEDICAL SILICONE PESSARY | HHW | 2003-11-18 | 194 |
| K021876 | MAS WITH OR WITHOUT SYRINGE | HHK | 2003-04-08 | 305 |
| K023725 | HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 | GDW | 2003-02-03 | 89 |
| K010296 | UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 | LKF | 2001-04-11 | 70 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-04-09.
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 Marina Medical Instruments, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Marina Medical Instruments, Inc.” (first 2001, latest 2005), across 5 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 Marina Medical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marina Medical Instruments, Inc. is 194 days.
Which FDA product codes appear under Marina Medical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 1); HHK (Curette, Suction, Endometrial (And Accessories), 1); HHW (Pessary, Vaginal, 1).
Next steps
- See all 5 Marina Medical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Marina Medical 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.