Data / Medical devices / United States / Schoelly Usa Inc.
Schoelly Usa Inc.: FDA-registered device maker in Northborough, MA, United States, 4 510(k) clearances
Schoelly Usa Inc. is registered with the FDA (registration 3016667340) in Northborough, MA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 9, 2015. Registered through 2027. 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
- 3016667340
- Address
- 360 Church St. Suite 130, Northborough, MA, United States, 01532
- Owner or operator
- SCHOELLY USA Inc. (10061682)
- Roles
- Manufacturer
- First device listed
- February 20, 2020
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 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 |
|---|---|---|---|---|---|---|
| March 9, 2015 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| December 5, 2014 | K143221 | Schoelly Laparoscope | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| June 2, 2014 | K133682 | SCHOELLY ARTHROSCOPE | HRX | Substantially Equivalent | Scholly Fiberoptic GmbH | accessdata.fda.gov |
| January 10, 2002 | K014250 | 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 | GCJ | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Arthroscope
- All makers of Hysteroscope (And Accessories)
- All makers of Cystoscope And Accessories, Flexible/Rigid
Updated March 9, 2015. 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.