Data / Medical devices / Vaginal Hydrogel Packing System
Vaginal Hydrogel Packing System (QXR): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Vaginal Hydrogel Packing System (product code QXR, Class 2, 21 CFR 892.5735). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 22, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QXR
- Device class
- 2
- Regulation
- 892.5735
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| South Korea | 1 |
Makers of Vaginal Hydrogel Packing System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kbbio Co., Ltd. | Seongnam Gyeonggi, South Korea | Manufacturer | 1 | August 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medtec LLC | Orange City, IA, United States | Manufacturer, Specification developer | 1 | August 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Aptyx - Charlotte | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 22, 2023. 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.