Data / Medical devices / United States / Beaver-Visitec International, Inc
Beaver-Visitec International, Inc: FDA-registered device maker in Little Silver, NJ, United States, 2 510(k) clearances
Beaver-Visitec International, Inc is registered with the FDA (registration 2247224) in Little Silver, NJ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 22, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2247224
- FEI number
- 1000122089
- Address
- 39 Sycamore Avenue, Little Silver, NJ, United States, 07739
- Owner or operator
- Beaver-Visitec International, Inc. (10023467)
- Roles
- Manufacturer
- First device listed
- November 26, 2007
- Registered through
- 2026
- Brand names listed
- E2 Compact Microprobe and Endoscopy System, E2 Microprobe Laser & Endoscopy System, E4 Endoscopy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscope, Ophthalmic | KYH | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| November 22, 2004 | K042918 | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 | GEX | Substantially Equivalent | Endooptiks, Inc. | accessdata.fda.gov |
| May 28, 1991 | K910532 | URAM OPHTHALMIC LASER ENDOSCOPE | HQF | Substantially Equivalent | Martin S. Knopf Assoc., Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2004. 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.