Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004105270

FEI Number

3004105270

Entity Name

PLEXUS CORP.

City/State/Country

BUFFALO GROVE, IL, US

Establishment Address

2400 Millbrook Dr, BUFFALO GROVE, IL 60089, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PLEXUS CORP. (Owner Number: 3019588)

Owner / Operator Contact Address

ONE PLEXUS WAY, --, Neenah, WI 54956, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dexcom G6 Continuous Glucose Monitoring System Revolve System PMPAMP71 INVOS Preamplifier Legacy EX/ST system Hugo Robotically Assisted Surgery (RAS) System Genmark EPLEX Urology RFG3 Generator HexaFlow Irrigation Pump - AFR-00005 Sphere S9 Catheter Extension Cable HexaGen RF Generator - AFR-00004 HexaPulse PF Generator - AFR-00008 Latitude 3300 Stealth Autoguide System Pre-Amp PMPAMP71 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (Control module and Holster) Cryocath system Urology Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (Holster) Affera Integrated Mapping System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2018-07-31
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-08-19
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-02-25
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2022-02-25
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-08-19
SCV	Modular Electromechanical Surgical System	General, Plastic Surgery	Class 2	878.4964	2026-01-02
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2018-05-23
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-09-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-08-18
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2025-06-30
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-06-30
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2025-06-30
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2017-11-29
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-06
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2019-02-13
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2019-02-13
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-09-08
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2013-01-25
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-09-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PLEXUS CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011606051	PLEXUS SERVICES RO SRL	Oradea Bihor, RO
3034431159	Plexus (Thailand) Co., Ltd.	Amphur Bang Pakong Chachoengsao, TH
3008754394	Plexus Corp. (UK) Limited	Kelso Scottish Borders, The, GB
3006063136	Plexus (Xiamen) Co. Ltd.,	Xiamen, Fujian, CN
2183715	PLEXUS CORP.	Neenah, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K201432	Masimo Corporation	Masimo O3 Regional Oximeter System	2020-08-29
K211561	Covidien, LLC	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)	2021-12-05
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004105270. Last updated year: 2026. Please use registration number 3004105270 when referencing this establishment in official correspondence.