Nypro Inc (Maple Grove)

FDA Device Registration & Listing · Maple Grove, MN, US · Registration 3011024991

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011024991
FEI Number
3011024991
Entity Name
Nypro Inc (Maple Grove)
City/State/Country
Maple Grove, MN, US
Establishment Address
11400 73rd Ave N Ste 100, Maple Grove, MN 55369, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Jabil Inc. (Owner Number: 9074019)
Owner / Operator Contact Address
10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Scalpel, ultrasonic, reprocessed General Surgical Electrosurgical, cutting and coagulation J&J Reprocessed Forceps, obstetrical Implantable Clip Cutting and Coagulation accessories Reprocessed electrosurgical cutting and coagulation accessories laparoscopic and endoscopic Oximeter APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Surgical Drill Ultrasound Catheter J&J Reprocessed intravascular ultrasound catheter J&J Reprocessed Knife, Ear Scalpel, ultrasonic, reprocessed Catheter Biopsy Forceps Laparoscope OXIMETER, REPROCESSED LEAF Patient Monitoring System Bed Patient Monitor chisel Ultrasonic Instrument, Ultrasonic Scalpel Catheter, Recording, Electrode, Reprocessed CATHETER, RECORDING, ELECTRODE, REPROCESSED J&J Reprocessed Knife, Orthopedic Laparoscope Oximeter HANDLE, SCALPEL Handle Reprocessed intravascular ultrasound catheter Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument Ultrasonic scalpel Oximeter Reprocessed DECANAV Electrophysiology Catheter Catheter, recording, electrode, reprocessed Saw Blade LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED Laparoscope Arthroscope ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED Catheter LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED Fixation Appliance Catheter ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED Metallic Pin CATHETER, RECORDING, ELECTRODE, REPROCESSED Reprocessed catheter introducer Catheter Introducer Fixation Component Ultrasonic Scalpel Cable Electrode

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2018-08-25
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2018-08-10
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-08-15
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2018-08-26
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2020-01-21
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2024-01-19
HDA Forceps, Obstetrical Obstetrics/Gynecology Class 2 884.4400 2018-08-26
NMJ Clip, Implantable, Reprocessed General, Plastic Surgery Class 2 878.4300 2018-08-10
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-08-14
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-08-14
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-08-25
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2018-08-10
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-08-25
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2018-08-10
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2018-08-14
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2018-08-25
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2019-09-04
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2018-08-26
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2018-08-15
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-14
NLU Forceps, Biopsy, Electric, Reprocessed Gastroenterology, Urology Class 2 876.4300 2018-08-10
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2020-02-11
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2018-08-14
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2018-08-24
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2018-08-15
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-08-13
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-08-10
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2018-08-10
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-15
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-24
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2018-08-26
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2018-08-14
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2018-08-14
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2018-08-26
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2018-08-24
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-01-15
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2018-08-14
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2018-08-14
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2024-11-07
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-11-07
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-24
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2018-08-10
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2018-08-24
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-08-25
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2018-08-13
NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed Cardiovascular Class 2 870.1220 2021-08-24
HRX Arthroscope Orthopedic Class 2 888.1100 2018-08-10
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-08-24
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-13
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2018-08-15
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2018-08-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-08-15
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2018-08-15
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-08-10
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-10
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-08-15
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-08-10
NDM Pin, Fixation, Threaded, Metallic Orthopedic Class 2 888.3040 2018-08-10
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-08-24
PNE Reprocessed Catheter Introducer Cardiovascular Class 2 870.1340 2018-08-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-08-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-08-14
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2018-08-10
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2018-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jabil Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
3011246727 Jabil Circuit Sdn. Bhd. Bayan Lepas Pulau Pinang, MY
3003512059 NYPRO DR, LLC (Bldg 11) Haina San Cristobal, DO
3004730544 NYPRO DR, LLC (Building 52) Haina San Cristobal, DO
1424235 Nypro Inc. (Chicago) GURNEE, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K232130 Surgical Instrument Services and Savings, Inc. Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter 2023-12-15
K230934 ABBOTT MEDICAL ViewFlex™ Eco Reprocessed ICE Catheter 2023-05-03
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17
K150357 Sterilmed, Inc. Reprocessed Electrophysiology Diagnostic Catheters 2015-08-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0332-2022 Covidien Llc U
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011024991. Last updated year: 2026. Please use registration number 3011024991 when referencing this establishment in official correspondence.
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