Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032521

FEI Number

3003574398

Entity Name

PRO-TECH DESIGN & MFG., INC.

City/State/Country

SANTA FE SPRINGS, CA, US

Establishment Address

14561 MARQUARDT AVE., SANTA FE SPRINGS, CA 90670, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRO-TECH Design & Mfg, Inc. (Owner Number: 9048910)

Owner / Operator Contact Address

14561 MARQUARDT AVE., --, Santa Fe Springs, CA 90670, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Piston Syringe VETRUN - Pre-Lubricated Nasopharyngeal Airway, Made in USA Metatarsal Decompression Implant Hemiphalangeal Implant System Xenoscope Xenoscope SurgView Integrated Visualization System Metatarsal Decompression Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-01-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-01-20
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-01-20
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2012-10-22
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2015-01-20
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Orthopedic	Class 2	888.3800	2015-01-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2015-01-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-01-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-01-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-01-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-01-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-06-13
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2023-09-25
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2015-01-20
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2015-01-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-01-20
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2015-01-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-01-20
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2015-01-20
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2022-01-27
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-01-20
SEP	Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay	Microbiology	Class 2	866.2920	2026-04-29
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2012-10-22
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2021-04-14
PMP	Dorsal Root Ganglion Stimulator For Pain Relief	Unknown	Class 3	N/A	2023-12-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-01-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-11-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-11-05
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2012-10-15
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-04-25
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2012-10-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-24
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-07-24
QPY	Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation	Unknown	Class 3	N/A	2025-03-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-01-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-24
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-07-24
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2015-01-20
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2012-10-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2012-10-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2012-10-22
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2012-10-22
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2012-10-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2012-10-22
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2012-10-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2012-10-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2012-10-22
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2012-10-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-11-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-11-05
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2012-10-22
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2012-10-22
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2012-10-22
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2020-05-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-05-04
GCQ	Endoscope, Flexible	Gastroenterology, Urology	Class 2	876.1500	2020-05-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-01-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-01-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-10-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-10-15
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2015-01-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-01-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-01-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-01-20
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2012-10-22
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2012-10-22
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2012-10-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2012-10-22
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2012-10-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2012-10-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2012-10-22
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2012-10-22
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2012-10-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2012-10-22
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2024-01-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-01-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-11-22
GCQ	Endoscope, Flexible	Gastroenterology, Urology	Class 2	876.1500	2022-11-22
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2018-03-12
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2022-01-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2015-01-20
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2012-10-22
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-01-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-01-20
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2012-10-15
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2022-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRO-TECH Design & Mfg, 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
3010531069	PRO-TECH Design & Mfg, Inc.	Arlington, TX, US
3013023969	PRO-TECH Design & Mfg, Inc.	Santa Fe Springs, CA, US
2183319	SURGICAL TECHNOLOGIES, INC.	ST. PAUL, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0002-2007	Guidant Corporation	3	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032521. Last updated year: 2026. Please use registration number 2032521 when referencing this establishment in official correspondence.