Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2249529

FEI Number

3002786339

Entity Name

GSOURCE, LLC.

City/State/Country

EMERSON, NJ, US

Establishment Address

19 Bland St, EMERSON, NJ 07630, US

Establishment Type(s)

Reprocess Single-Use Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GSOURCE, LLC. (Owner Number: 9038732)

Owner / Operator Contact Address

19 BLAND STREET, --, Emerson, NJ 07630, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Key Elevator gS Forceps Chisel/Osteotome, Surgical gsource gSource gSource gSource Retractor, Self-retaining Trephine gS gSource gS gS Foreceps gSource gSource gS Curette cleaning brushes gSource Cutter, Wire Cerclage Wire Rongeur Retractor, Non-self-reataining Screwdriver gSource gSource gSource gSource Curette, Surgical, General gS gS Elevator, Surgical, General gS Bit, Drill gSource Hemostat Brun gSource Foreps, wire holding gSource Cannula Suction gRack gSource Mallet, surgical, general Passer, Wire, orthopedic gSource Instrument, Cast Application/Removal Osteotome gS gSource gSource gSource scalpel handle Probe gSource Gauge, Depth Punch, surgical Knife, Amputation File, Bone, Surgical gsource Hook, Bone Pliers, Surgical Forceps, Rongeur, Surgical Cerclage Wires wire Elevator gSource gSource gSource gS Orthopedic Manual Surgical Instrument Dialator, tracheal Hook, Surgical, General

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2015-08-20
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-05-18
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-08-14
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2010-12-30
HTO	Reamer	Orthopedic	Class 1	888.4540	2020-09-01
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-09-21
HTQ	Broach	Orthopedic	Class 1	888.4540	2025-01-10
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2019-12-17
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2019-08-28
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2010-12-30
HWK	Trephine	Orthopedic	Class 1	888.4540	2010-12-30
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2019-11-14
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2022-06-01
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-05-18
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-05-18
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2010-12-30
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2019-11-25
HTP	File	Orthopedic	Class 1	888.4540	2019-12-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-31
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2019-11-14
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2010-12-30
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-07-15
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-12-17
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2013-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-07-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-07-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-07-07
HTX	Rongeur	Orthopedic	Class 1	888.4540	2010-12-30
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2010-12-30
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2010-12-30
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2024-07-31
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-12-11
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-07-15
HXC	Wrench	Orthopedic	Class 1	888.4540	2025-01-10
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-12-30
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2020-05-18
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2020-05-18
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-12-30
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2019-11-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2010-12-30
HWB	Extractor	Orthopedic	Class 1	888.4540	2024-08-06
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2010-12-30
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2015-08-20
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-12-11
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2010-12-30
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2020-01-31
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-01-09
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-11-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-07-16
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2023-09-21
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-12-30
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2010-12-30
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-31
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2019-11-25
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2010-12-30
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2010-12-30
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2019-11-14
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2019-12-17
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-11-25
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2019-06-03
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2023-11-13
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-12-30
HXB	Probe	Orthopedic	Class 1	888.4540	2010-12-30
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2023-09-21
HWW	Countersink	Orthopedic	Class 1	888.4540	2017-11-13
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2010-12-30
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-12-30
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2010-12-30
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2010-12-30
HWQ	Passer	Orthopedic	Class 1	888.4540	2020-09-01
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2010-12-30
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-12-30
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2010-12-30
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-01-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2017-01-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2016-09-27
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2016-09-27
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2010-12-30
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2021-04-09
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2020-01-08
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-12-17
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2023-09-21
KTZ	Caliper	Orthopedic	Class 1	888.4150	2015-10-06
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-04-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-29
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2010-12-30
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-08-28
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-12-30
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2020-01-08
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-08-28

Official Correspondent

Jinay Dalal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GSOURCE, LLC.

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2249529. Last updated year: 2026. Please use registration number 2249529 when referencing this establishment in official correspondence.