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Data / Medical devices / United States / Surgix Medical LLC

Surgix Medical LLC: FDA-registered device maker in Spring, TX, United States, 8 510(k) clearances

Surgix Medical LLC is registered with the FDA (registration 3012995405) in Spring, TX, United States. It lists 102 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 8, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3012995405
Address
22317 Gosling RD, Spring, TX, United States, 77389
Owner or operator
Surgix Medical, L.L.C. (10052923)
Roles
Repackager or relabeler, Specification developer
First device listed
December 17, 2021
Registered through
2026
Brand names listed
Amputation Knife, Antrum Punch, Bender, Blade, Saw, General & Plastic Surgery, Bone Chisel, Bone Impactor, Bone Skid, Bowman Probe and more

Devices it lists

DeviceProduct codeClassRoleSource
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
BenderHXW1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, VentricularHCD1Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeleraccessdata.fda.gov
Chisel, Middle-EarJYE1Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Clamp, VascularDXC2Repackager or relabeleraccessdata.fda.gov
Crimper, Wire, Ent, Non-SterileNNN1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Depressor, OrbitalHNX1Repackager or relabeleraccessdata.fda.gov
Dilator, CatheterGCC1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Excavator, EarJYH1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Repackager or relabeleraccessdata.fda.gov
Fork, TuningGWX1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Repackager or relabeleraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Handpiece (Brace), DrillHBD1Repackager or relabeleraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Repackager or relabeleraccessdata.fda.gov
ImpactorHWA1Repackager or relabeleraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Repackager or relabeleraccessdata.fda.gov
Irrigator, SinusKAR1Repackager or relabeleraccessdata.fda.gov
Knife, AmputationGDN1Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Repackager or relabeleraccessdata.fda.gov
Nipper, MalleusJYR1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Probe, TrabeculotomyHNK1Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Repackager or relabeleraccessdata.fda.gov
Rod, Measuring EarJYZ1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Rongeur, ManualHAE2Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Repackager or relabeleraccessdata.fda.gov
Skid, BoneHWO1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Ac-PoweredJEA1Specification developeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 8, 2018K172661Fetzer Medical Gynecological ForcepsHCZSubstantially EquivalentFetzer Medical GmbH & Co. KGaccessdata.fda.gov
June 29, 2017K163524Vessel DilatorDWPSubstantially EquivalentFetzer Medical GmbH & Co. KGaccessdata.fda.gov
September 9, 2016K161004Self-retaining RetractorGZTSubstantially EquivalentFetzer Medical GmbH & Co. KGaccessdata.fda.gov
February 29, 2016K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursHAESubstantially EquivalentK2 Medical GmbH & Co. KGaccessdata.fda.gov
May 10, 2013K123478STINGRAY BIPOLAR FORCEPSGEISubstantially EquivalentStingray Surgical Productsaccessdata.fda.gov
April 30, 2012K120492K2 MEDICAL VASCULAR CLAMPSDXCSubstantially EquivalentK2 Medical GmbH & Co. KGaccessdata.fda.gov
December 3, 2009K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov

Compare with other makers

Updated May 8, 2018. 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.