Data / Medical devices / United States / Surgin Surgical Instrumentation, Inc.
Surgin Surgical Instrumentation, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 1 510(k) clearance
Surgin Surgical Instrumentation, Inc. is registered with the FDA (registration 2023739) in Scottsdale, AZ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 1989. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2023739
- Address
- 10040 E. Happy Valley Rd. Unit # 415, Scottsdale, AZ, United States, 85255
- Owner or operator
- SURGIN SURGICAL INSTRUMENTATION, INC. (2023739)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 24, 2006
- Registered through
- 2026
- Brand names listed
- DoseRite, HEMORRHAGE OCCLUDOR, Releve, Salgado Driver
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hammer, Surgical | FZY | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 23, 1989 | K890447 | HEMORRHAGE OCCLUDOR | GDW | Substantially Equivalent | Surgeon Surgical Instrumentation, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Staple, Implantable
- All makers of Instrument, Manual, General Obstetric-Gynecologic
- All makers of Hammer, Surgical
Updated February 23, 1989. 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.