FDA Registration
Active
🇺🇸 United States
GSOURCE, LLC.
Reg #: 2249529
·
FEI: 3002786339
·
Expires 2026
Products
117
Proprietary Names
64
Establishment Types
4
Classifications
117
Registration Details
- Registration Name
- GSOURCE, LLC.
- Registration Number
- 2249529
- FEI Number
- 3002786339
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 19 Bland St
- City
- EMERSON
- State
- NJ
- ZIP
- 07630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102845
Owner / Operator
- Firm Name
- GSOURCE, LLC.
- Operator Number
- 9038732
- Address
- 19 BLAND STREET, --
- City
- Emerson
- State
- NJ
- Postal Code
- 07630
- Country
- US
- Correspondent
- Jinay Dalal
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2015-08-20 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2020-05-18 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2010-12-30 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-09-01 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2023-09-21 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2025-01-10 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2019-12-17 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2019-08-28 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2010-12-30 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2010-12-30 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2019-11-14 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2022-06-01 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2020-05-18 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2020-05-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 2019-11-25 |
| File | HTP | Class 1 | Orthopedic | No | 2019-12-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2019-11-14 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-07-15 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2019-12-17 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-01-29 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-07-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2023-07-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-07-07 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2010-12-30 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2010-12-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2010-12-30 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2024-07-31 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-12-11 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2020-07-15 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2025-01-10 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2020-05-18 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2020-05-18 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2019-11-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2010-12-30 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2024-08-06 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2015-08-20 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2019-12-11 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2020-01-31 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2014-01-09 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2017-11-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-07-16 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2023-09-21 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2010-12-30 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-31 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2019-11-25 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2010-12-30 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2019-11-14 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2019-12-17 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2019-11-25 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2019-06-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Probe | HXB | Class 1 | Orthopedic | No | 2010-12-30 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2023-09-21 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2017-11-13 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2010-12-30 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2010-12-30 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2020-09-01 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2010-12-30 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2017-01-20 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2021-04-09 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2020-01-08 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2019-12-17 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2023-09-21 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2015-10-06 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2020-04-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-29 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2010-12-30 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2019-08-28 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2020-01-08 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2019-08-28 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2020-09-01 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2015-08-20 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2019-12-17 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2020-05-18 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2015-08-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-08-22 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2019-08-28 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2010-12-30 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2020-07-15 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2010-12-30 |
| Bender | HXW | Class 1 | Orthopedic | No | 2010-12-30 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2010-12-30 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2019-12-17 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2010-12-30 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2010-12-30 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2010-12-30 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2010-12-30 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2015-08-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2015-08-20 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2010-12-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-11-13 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2020-12-01 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2015-08-20 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2010-12-30 |
Proprietary Names
Key Elevator
gS
Forceps
Chisel/Osteotome, Surgical
gsource
gSource
Retractor, Self-retaining
Trephine
Foreceps
Curette
cleaning brushes
Cutter, Wire
Cerclage Wire
Rongeur
Retractor, Non-self-reataining
Screwdriver
Curette, Surgical, General
Elevator, Surgical, General
Bit, Drill
Hemostat
Brun
Foreps, wire holding
Cannula Suction
gRack
Mallet, surgical, general
Passer, Wire, orthopedic
Instrument, Cast Application/Removal
Osteotome
scalpel handle
Probe
Gauge, Depth
Punch, surgical
Knife, Amputation
File, Bone, Surgical
Hook, Bone
Pliers, Surgical
Forceps, Rongeur, Surgical
Cerclage Wires
wire
Elevator
Orthopedic Manual Surgical Instrument
Dialator, tracheal
Hook, Surgical, General
Tape, Measuring, Rulers and Calipers
Universal Pliers
Saw
Lambotte
Template
Cutter, Surgical
Ring cutter
Awl
Bender
Chisel, Bone, Surgical
Goniometer
Holder, Needle, Orthopedic
Scissors, Orthopedic, Surgical
Rasp
Clamp, Surgical, General
Twister, Wire
mallet
Leksell Stille
Gouge, Surgical, General
Metz
Tamp
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Reprocess Single-Use Device