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Data / Medical devices / United States / Surgical Direct, Inc.

Surgical Direct, Inc.: FDA-registered device maker in Orange City, FL, United States, 6 510(k) clearances

Surgical Direct, Inc. is registered with the FDA (registration 3003687489) in Orange City, FL, United States. It lists 29 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 20, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Surgical Direct, Inc.
FDA registration number
3003687489
Address
811 Harley Strickland Blvd, Orange City, FL, United States, 32763
Owner or operator
SURGICAL DIRECT, INC. (9051277)
Roles
Repackager or relabeler
First device listed
January 9, 2008
Registered through
2026
Brand names listed
Surgical Direct

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Repackager or relabeleraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)HIN2Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Osteotome, ManualGFI1Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager 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
December 20, 2019K193018Surgical Direct Hand-held Laparoscopic InstrumentsGEISubstantially EquivalentSurgical Direct, Inc.accessdata.fda.gov
December 5, 2014K143221Schoelly LaparoscopeGCJSubstantially EquivalentSchoelly Fiberoptic GmbHaccessdata.fda.gov
March 2, 2007K060899FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPEFAJSubstantially EquivalentSchoelly Imaging, Inc.accessdata.fda.gov
April 21, 1998K974382ACKERMANN SURGICAL INSTRUMENTSGCJSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov
November 15, 1994K926517ELMED LBC 50-PHINSubstantially EquivalentElmed, Inc.accessdata.fda.gov
May 2, 1994K932938ELMED ESU 300 M/M AND DIGITALGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov

Compare with other makers

Updated December 20, 2019. 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.