Data / Medical devices / United States / Surgical Principals, Inc. - Spi
Surgical Principals, Inc. - Spi: FDA-registered device maker in Tacoma, WA, United States, 2 510(k) clearances
Surgical Principals, Inc. - Spi is registered with the FDA (registration 3004044817) in Tacoma, WA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004044817
- Address
- 1625 South Tacoma Way, Tacoma, WA, United States, 98409
- Owner or operator
- Surgical Principals, Inc. - SPI (10062309)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- October 19, 2021
- Registered through
- 2026
- Brand names listed
- LaproGlilde, LaproSac, LaproShear
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | 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 |
|---|---|---|---|---|---|---|
| September 22, 2025 | K251743 | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | GCJ | Substantially Equivalent | Surgical Principals, Inc. | accessdata.fda.gov |
| August 16, 2021 | K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | GEI | Substantially Equivalent | Dannik, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Laparoscope, General & Plastic Surgery
Updated September 22, 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.