Medgyn Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medgyn Products, Inc.” (first 1988, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 101 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 | 1 | 259 |
| 2014 | 0 | — |
| 2015 | 1 | 334 |
| 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 |
|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | 2 | 2 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 1 | 1 |
| HGF | Source, Abortion Unit, Vacuum | 1 | 1 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Medgyn Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | MQF | 2015-11-23 | 334 |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | HEX | 2013-06-12 | 259 |
| K945179 | BOTTLE COLLECTION SET | HGF | 1995-01-26 | 94 |
| K880196 | LAMINARIA | HDY | 1988-05-06 | 101 |
| K880195 | GYNESCOPE | HEX | 1988-03-14 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Medgyn Products, 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 Medgyn Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medgyn Products, Inc.” (first 1988, latest 2015), across 4 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 Medgyn Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medgyn Products, Inc. is 101 days.
Which FDA product codes appear under Medgyn Products, Inc.?
The most frequent FDA product codes under this applicant name are HEX (Colposcope (And Colpomicroscope), 2); HDY (Dilator, Cervical, Hygroscopic-Laminaria, 1); HGF (Source, Abortion Unit, Vacuum, 1).
Next steps
- See all 5 Medgyn Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEX, Medgyn Products, 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.