Data / Medical devices / Germany / Gynemed GMBH & Co. KG
Gynemed GMBH & Co. KG: FDA-registered device maker in Sierksdorf Schleswig-Holstein, Germany, 4 510(k) clearances
Gynemed GMBH & Co. KG is registered with the FDA (registration 3030390242) in Sierksdorf Schleswig-Holstein, Germany. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated November 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030390242
- Address
- Wagrienring 24b, Sierksdorf Schleswig-Holstein, Germany, 23730
- Owner or operator
- GYNEMED GmbH & Co. KG (10091740)
- Roles
- Manufacturer
- First device listed
- December 11, 2024
- Registered through
- 2026
- Brand names listed
- GM501 MineralOil, GM501 SpermActive, GM501 SpermAir, GM501 Wash, GM501 Wash with Phenolred and Gentamicin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2020 | K192503 | GM501 Wash with Phenol Red and Gentamicin | MQL | Substantially Equivalent | Hamilton Thorne Incorporated | accessdata.fda.gov |
| April 23, 2020 | K192644 | GM501 SpermAir and GM501 SpermActive | MQL | Substantially Equivalent | Hamilton Thorne Incorporated | accessdata.fda.gov |
| September 18, 2019 | K191552 | GM501 Mineral Oil | MQL | Substantially Equivalent | Hamilton Thorne, Inc. | accessdata.fda.gov |
| September 5, 2019 | K190383 | GM501 Wash | MQL | Substantially Equivalent | Hamilton Thorne, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.