Data / Medical devices / United States / Gsource, LLC.
Gsource, LLC.: FDA-registered device maker in Emerson, NJ, United States, 5 510(k) clearances
Gsource, LLC. is registered with the FDA (registration 2249529) in Emerson, NJ, United States. It lists 117 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 9, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2249529
- FEI number
- 3002786339
- Address
- 19 Bland St, Emerson, NJ, United States, 07630
- Owner or operator
- GSOURCE, LLC. (9038732)
- Roles
- Contract manufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- December 30, 2010
- Registered through
- 2026
- Brand names listed
- Awl, Bender, Bit, Drill, Brun, Cannula Suction, Cerclage Wire, Cerclage Wires, Chisel, Bone, Surgical and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Applier, Hemostatic Clip | HBT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Brush, Biopsy, General & Plastic Surgery | GEE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| File | HTP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Nasal | KAS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Reprocessor, Specification developer | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Tonsil Suturing | KBR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pinwheel | GWY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Non-Self-Retaining | FGN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saw | HSO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Umbilical | HDJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Orthopedic | HXR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spoon, Ophthalmic | HNB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spud, Ophthalmic | HNA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Contract manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trephine | HWK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2016 | K162600 | Jewel Precision Reusable Rigid Sterilization Container System | KCT | Substantially Equivalent | Jewel Precision Sheet Metal & Machine, Inc. | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
| September 10, 2010 | K100736 | KIRSCHNER AND GUIDE WIRES | HTY | Substantially Equivalent | Smt Schilling Metalltechnik GmbH | accessdata.fda.gov |
| March 25, 2003 | K030665 | BONE WIRE | HTY | Substantially Equivalent | Stork Instrumente GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Gouge, Surgical, General & Plastic Surgery
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Saw
- All makers of Clamp, Surgical, General & Plastic Surgery
- All makers of Needle, Tonsil Suturing
- All makers of Holder, Needle; Orthopedic
Updated December 9, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.