Data / Medical devices / United States / Integrated Endoscopy, Inc.
Integrated Endoscopy, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Integrated Endoscopy, Inc. is registered with the FDA (registration 3011401113) in Irvine, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 20, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011401113
- Address
- 16 Technology Drive, Suite 165, Irvine, CA, United States, 92618
- Owner or operator
- Integrated Endoscopy, Inc. (10048466)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 15, 2015
- Registered through
- 2027
- Brand names listed
- IE18CMT, IE20CMT, IE4030, IE4030-10, IE4030ATX, IE4030ATX-10, IE4030SNN, IE4030SNN-10 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 20, 2025 | K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | GCJ | Substantially Equivalent | Integrated Endoscopy, Inc. | accessdata.fda.gov |
| July 11, 2019 | K191594 | Nuvis Battery Arthroscope | HRX | Substantially Equivalent | Integrated Endoscopy, Inc. | accessdata.fda.gov |
| July 17, 2014 | K140903 | NUVIS ARTHROSCOPE | HRX | Substantially Equivalent | Integrated Endoscopy, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Arthroscope
- All makers of Accessories, Arthroscopic
Updated November 20, 2025. 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.