Data / Medical devices / United States / General Scientific Corp.
General Scientific Corp.: FDA-registered device maker in Ann Arbor, MI, United States, 1 510(k) clearance
General Scientific Corp. is registered with the FDA (registration 1834177) in Ann Arbor, MI, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1834177
- FEI number
- 1000160378
- Address
- 77 Enterprise Dr, Ann Arbor, MI, United States, 48103
- Owner or operator
- General Scientific Corporation (9009191)
- Roles
- Manufacturer
- First device listed
- June 24, 2008
- Registered through
- 2026
- Brand names listed
- SurgiCam, SurgiCam HD, SurgiCam Pro, SurgiTel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Cine, Surgical, With Audio | FWI | 1 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Spectacle, Operating (Loupe), Ophthalmic | HOH | 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 |
|---|---|---|---|---|---|---|
| January 25, 1994 | K934494 | SURGITEL | HOH | Substantially Equivalent | General Scientific Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Spectacle, Operating (Loupe), Ophthalmic
Updated January 25, 1994. 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.