Data / Medical devices / United States / Kronner Prototypes, Inc.
Kronner Prototypes, Inc.: FDA-registered device maker in Roseburg, OR, United States, 2 510(k) clearances
Kronner Prototypes, Inc. is registered with the FDA (registration 3018984) in Roseburg, OR, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018984
- Address
- 1443 Upper Cleveland Rapids RD, Roseburg, OR, United States, 97471
- Owner or operator
- KRONNER PROTOTYPES, INC. (3018984)
- Roles
- Manufacturer
- First device listed
- July 14, 1992
- Registered through
- 2026
- Brand names listed
- KRONNER FOOT CASTING STAND, KRONNER LOW PROFILE SCOPE HOLDER, Kronner Retractor, Kronner Side-Kick Uterine Manipulator Holder, VCM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | 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 |
|---|---|---|---|---|---|---|
| December 11, 2013 | K130758 | KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER | LKF | Substantially Equivalent | Kronner Prototypes, Inc. | accessdata.fda.gov |
| May 2, 2000 | K000663 | KRONNER LOW PROFILE SCOPE HOLDER | GCJ | Substantially Equivalent | Kronner Prototypes, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor
- All makers of Retractor, Vaginal
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Instrument, Cast Application/Removal, Manual
Updated December 11, 2013. 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.