Data / Medical devices / United States / Surgistar, Inc.
Surgistar, Inc.: FDA-registered device maker in Vista, CA, United States, 2 510(k) clearances
Surgistar, Inc. is registered with the FDA (registration 2028661) in Vista, CA, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 16, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028661
- FEI number
- 3005765014
- Address
- 2310 la Mirada Dr, Vista, CA, United States, 92081
- Owner or operator
- SURGISTAR, INC. (9005898)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 28, 1992
- Registered through
- 2026
- Brand names listed
- Cannula, Knife, Ophthalmic Cannula, Scalpel, Trephine
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cystotome | HNY | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 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 |
|---|---|---|---|---|---|---|
| May 16, 1996 | K961524 | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS | HNY | Substantially Equivalent | Sterilab, Inc. | accessdata.fda.gov |
| September 9, 1992 | K923689 | SURGISTAR BLADES | GDX | Substantially Equivalent | Surgistar, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Scalpel, One-Piece
- All makers of Knife, Surgical
- All makers of Trephine, Manual, Ophthalmic
- All makers of Cannula, Ophthalmic
- All makers of Instrument, Surgical, Disposable
- All makers of Needle, Aspiration And Injection, Disposable
Updated May 16, 1996. 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.