Data / Medical devices / United States / Pristine Surgical LLC
Pristine Surgical LLC: FDA-registered device maker in Palm Harbor, FL, United States, 1 510(k) clearance
Pristine Surgical LLC is registered with the FDA (registration 3019766696) in Palm Harbor, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019766696
- Address
- 34125 Us Hwy 19 N Ste 200, Palm Harbor, FL, United States, 34684
- Owner or operator
- Pristine Surgical LLC (10088394)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 13, 2023
- Registered through
- 2026
- Brand names listed
- Pristine Arthroscopic Visualization System, Summit High-Flow Cannula, Summit Single Use Arthroscope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 21, 2022 | K223244 | Pristine Arthroscopic Visualization System | HRX | Substantially Equivalent | Pristine Surgical | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2022. 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.