Data / Medical devices / United States / Andwin Scientific
Andwin Scientific: FDA-registered device maker in Simi Valley, CA, United States, 4 510(k) clearances
Andwin Scientific is registered with the FDA (registration 2027344) in Simi Valley, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 16, 1998. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2027344
- Address
- 167 W. Cochran St., Simi Valley, CA, United States, 93065
- Owner or operator
- THE ANDWIN CORP. (2027344)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 22, 1992
- Registered through
- 2026
- Brand names listed
- BORITEX, CYTEX ONE AND CYTEX TWO, Rovers Cervex-Brush, SAFETEX CERVICAL SCRAPER, SPECULITE CYALUME, Safetex, SealSafe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Manufacturer | accessdata.fda.gov |
| Filters, Cell Collection, Tissue Processing | KET | 1 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Screening, Urine | JXA | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Cervical, Cytological | HHT | 2 | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 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 16, 1998 | K983428 | SAFETEX CERVICAL SCRAPER (PLASTIC) | HHT | Substantially Equivalent | Andwin Scientific | accessdata.fda.gov |
| May 24, 1994 | K930955 | CERVEX-BRUSH | HHT | Substantially Equivalent | Rovers B.V. | accessdata.fda.gov |
| April 13, 1993 | K924908 | CELL COLLECTING BRUSH | HHT | Unknown | Anderson Winn Paper Co. | accessdata.fda.gov |
| March 16, 1989 | K890283 | CYTEX ONE AND CYTEX TWO | HHT | Substantially Equivalent | Anderson Winn Paper Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Spatula, Cervical, Cytological
- All makers of Kit, Screening, Urine
- All makers of Filters, Cell Collection, Tissue Processing
- All makers of Adaptor, Holder, Syringe
Updated November 16, 1998. 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.