Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020706315

FEI Number

3002783962

Entity Name

Pacira Pharmaceuticals, INC

City/State/Country

San Diego, CA, US

Establishment Address

10410 Science Center Drive, Building A,, San Diego, CA 92121, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Pacira Pharmaceuticals, Inc. (Owner Number: 10039578)

Owner / Operator Contact Address

Pacira Pharmaceuticals, Inc., 10450 Science Center Drive, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243677

PMA Number

N/A

All Registered Proprietary Names

Iovera System Gen 2 STIM ZILRETTA Set, i.V. Fluid transfer iovera° System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2022-10-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-10-20
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-10-29
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2025-12-04
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-12-04

Official Correspondent

John Toomey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pacira Pharmaceuticals, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

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1526711	ISOMEDIX OPERATIONS INC	GROVEPORT, OH, US
2011171	Sterigenics US LLC	Los Angeles, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020706315. Last updated year: 2026. Please use registration number 3020706315 when referencing this establishment in official correspondence.