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Data / Medical devices / United States / Delasco, LLC

Delasco, LLC: FDA-registered device maker in Plano, TX, United States, 9 510(k) clearances

Delasco, LLC is registered with the FDA (registration 1930126) in Plano, TX, United States. It lists 34 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Delasco, LLC
FDA registration number
1930126
Address
4001 E Plano Pkwy Ste 100, Plano, TX, United States, 75074
Owner or operator
Delasco, LLC (10053591)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
January 5, 2017
Registered through
2026
Brand names listed
26401, FORCEPS,BIPOLAR,MCPHERSON 3 1/2inSTRGHT.5MM-SMOOTH, 26402, FORCEPS, BIPOLAR, ADSON, 4 3/4inSTRGHT,1MM SMOOTH, 26403, FORCEPS,BIPOLAR,SEMKIN,5 1/2inSTRGHT .5MM SMOOTH, 26404, FORCEPS,BIPOLAR,CUSHING,6 1/2inSTRGHT,1MM SMOOTH, 26405, FORCEPS,BIPOLAR,CUSHING 7inSTRGHT, 1MM SMOOTH, 26406, FORCEPS,BIPOLAR,CUSHING,7in (GURSH)STRGHT,2MM,SMTH, 26407, FORCEPS,BIPOLAR,GERALD,7in STRGHT,1MM,SMOOTH TIP, 26408, FORCEPS,BIPOLAR,GERALD,7 1/4inBAYONET,1MM,SMOOTH and more

Devices it lists

DeviceProduct codeClassRoleSource
Brilliant GreenKJO1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Chlorazol Black EKJQ1Manufactureraccessdata.fda.gov
ClampHXD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Eosin YHYB1Manufactureraccessdata.fda.gov
Fixative, Formalin-ContainingLDY1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Giemsa StainHYF1Manufactureraccessdata.fda.gov
GlutaraldehydeIFT1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Hematoxylin Harris'SHYK1Manufactureraccessdata.fda.gov
HemostatHRQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Repackager or relabeleraccessdata.fda.gov
Methylene Blue, Tissue StainKFC1Manufactureraccessdata.fda.gov
Oil, ClearingIJZ1Manufactureraccessdata.fda.gov
Powered Microneedle DeviceQAI2Complaint file establishmentaccessdata.fda.gov
Punch, SurgicalLRY1Specification developeraccessdata.fda.gov
Ring CutterFNS1Repackager or relabeleraccessdata.fda.gov
Rose BengalKKI1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Complaint file establishmentaccessdata.fda.gov
Solution, Lugol'SIAM1Manufactureraccessdata.fda.gov
Stains, Dye SolutionLEE1Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Complaint file establishmentaccessdata.fda.gov
Toluidine BlueIAB1Manufactureraccessdata.fda.gov
Trypan BlueLGY1Manufactureraccessdata.fda.gov
Unit, Cautery, Thermal, Ac-PoweredHQO2Repackager or relabeler, Specification developeraccessdata.fda.gov
Unit, Cryosurgical, AccessoriesGEH2Repackager or relabeleraccessdata.fda.gov
Wright'S StainIAF1Manufactureraccessdata.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
August 11, 2023K230420Dr. pen Microneedling SystemQAISubstantially EquivalentGuangzhou Ekai Electronic Technology Co., Ltd.accessdata.fda.gov
March 20, 2003K024009CRYOPROBEGEHSubstantially EquivalentH&O Equipments, Nv/Saaccessdata.fda.gov
October 23, 2000K002341THERMAL CAUTERY UNIT, MODEL 150HQOSubstantially EquivalentGeiger Medical Technologies, Inc.accessdata.fda.gov
June 23, 2000K001173NYLON, NONABSORBABLE SURGICAL SUTURES USPGARSubstantially Equivalent for Some IndicationsCp Medicalaccessdata.fda.gov
May 23, 2000K001029GEIGER NEEDLE ADAPTER, MODEL 406GEISubstantially EquivalentGeiger Medical Technologies, Inc.accessdata.fda.gov
December 27, 1999K994075GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435GEISubstantially EquivalentGeiger Medical Technologies, Inc.accessdata.fda.gov
August 19, 1999K992149GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405GEISubstantially EquivalentGeiger Medical Technologies, Inc.accessdata.fda.gov
January 28, 1999K983852BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429GEISubstantially EquivalentGeiger Medical Technologies, Inc.accessdata.fda.gov
August 14, 1997K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEISubstantially EquivalentTecno Instruments (Usa), Inc.accessdata.fda.gov

Compare with other makers

Updated August 11, 2023. 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.