Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009420598

FEI Number

3009420598

Entity Name

Primo Medical Group, Inc

City/State/Country

W Bridgewater, MA, US

Establishment Address

375 West St, W Bridgewater, MA 02379, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Primo Medical Group, Inc (Owner Number: 9004401)

Owner / Operator Contact Address

75 Mill Street, Stoughton, MA 02072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vapotherm FELIX-1 Nico BrainPath Approach Procedure Pack (International OUS) Nico BrainPath Approach Procedure Pack (Domestic US) Karl Storz Electrode Dexterity Steerable Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-11-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-11-29
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2017-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-11-29
CBD	Bottle, Collection, Breathing System (Calibrated)	General Hospital	Class 2	880.6740	2020-12-08
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-01-24
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2017-12-11
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2017-08-18
OQL	Mesh, Surgical, Deployment Balloon	General, Plastic Surgery	Class 2	878.3300	2013-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-01-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
NZE	Hyperthermia Monitor	Cardiovascular	Class 2	870.5900	2017-09-15
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2017-11-30
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2013-05-08
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2013-01-30
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-12-11
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2017-10-13
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2023-11-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-12-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-12-11
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-10-13
OJG	Neurological Tray	Neurology	Class 1	882.4525	2019-02-12
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2017-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-18
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2023-07-18
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2023-07-18
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2017-10-13
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2017-11-30
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2018-09-05
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2017-11-30
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2017-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-04-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-12-10
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2012-12-10
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2017-12-11
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2017-04-23
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2026-06-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-11-30
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2017-12-11
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2019-09-23
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2019-09-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-23
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2019-09-23
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2019-09-23
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2018-09-07
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2013-03-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-30
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2017-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-08-10
OQL	Mesh, Surgical, Deployment Balloon	General, Plastic Surgery	Class 2	878.3300	2017-05-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-05-01
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2017-05-01
HJC	Esthesiometer, Ocular	Ophthalmic	Class 1	886.1040	2023-05-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-12-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-12-11
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2023-07-18
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Primo Medical Group, 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
1222928	Primo Medical Group, INC	STOUGHTON, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
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
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009420598. Last updated year: 2026. Please use registration number 3009420598 when referencing this establishment in official correspondence.