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Data / Medical devices / United States / Green Or LLC

Green Or LLC: FDA-registered device maker in Lakeville, MN, United States, 6 510(k) clearances

Green Or LLC is registered with the FDA (registration 3021477808) in Lakeville, MN, United States. It lists 24 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 19, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3021477808
Address
17685 Juniper Path Ste 314, Lakeville, MN, United States, 55044
Owner or operator
GREEN OR LLC (10083909)
Roles
Repackager or relabeler
First device listed
January 3, 2022
Registered through
2026
Brand names listed
Green OR Reprocessed Accessories, arthroscopic, Green OR Reprocessed ArthoCare Ablation Wand, Green OR Reprocessed ArthroCare ENT Coblator - private label, Green OR Reprocessed Awl, Green OR Reprocessed Bit, Drill, Green OR Reprocessed Blade, Saw, General & Plastic Surgery, Surgical, Green OR Reprocessed Blade, Scalpel, Green OR Reprocessed Bur and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Repackager or relabeleraccessdata.fda.gov
CountersinkHWW1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedNUJ2Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic Surgery, ReprocessedNLM2Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
PasserHWQ1Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Staple, Removable (Skin)GDT1Repackager or relabeleraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Repackager 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
March 19, 2018K173740Reprocessed DePuy Mitek Ablation WandNUJSubstantially EquivalentRenovo, Inc.accessdata.fda.gov
March 5, 2018K173741Reprocessed ArthoCare Ablation WandNUJSubstantially EquivalentRenovo, Inc.accessdata.fda.gov
February 21, 2018K172647Reprocessed ArthroCare ENT CoblatorNUJSubstantially EquivalentRenovo, Inc.accessdata.fda.gov
October 6, 2017K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLMSubstantially EquivalentRenovo, Inc.accessdata.fda.gov
October 5, 2017K172093Reprocessed Covidien TrocarNLMSubstantially EquivalentRenovo, Inc.accessdata.fda.gov
October 4, 2017K172092Reprocessed Shavers/BursHRXSubstantially EquivalentRenovo, Inc.accessdata.fda.gov

Compare with other makers

Updated March 19, 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.