Data / Medical devices / United States / Pacira Pharmaceuticals, INC
Pacira Pharmaceuticals, INC: FDA-registered device maker in San Diego, CA, United States, 4 510(k) clearances
Pacira Pharmaceuticals, INC is registered with the FDA (registration 3020706315) in San Diego, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020706315
- FEI number
- 3002783962
- Address
- 10410 Science Center Drive, Building A, San Diego, CA, United States, 92121
- Owner or operator
- Pacira Pharmaceuticals, Inc. (10039578)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- October 8, 2021
- Registered through
- 2026
- Brand names listed
- Iovera System Gen 2, Iovera System Gen 2 STIM, ZILRETTA Set, i.V. Fluid transfer, iovera° System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Surgical, Cryogenic | GXH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 26, 2024 | K243677 | iovera° System | GXH | Substantially Equivalent | Pacira Biosciences, Inc. | accessdata.fda.gov |
| May 20, 2022 | K220656 | iovera System | GXH | Substantially Equivalent | Pacira Biosciences, Inc. | accessdata.fda.gov |
| September 10, 2021 | K211334 | Iovera System | GXH | Substantially Equivalent | Pacira Pharmaceuticals, Inc. | accessdata.fda.gov |
| October 7, 1996 | K963583 | MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Device, Surgical, Cryogenic
- All makers of Stimulator, Nerve
Updated December 26, 2024. 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.