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Data / Medical devices / United States / Black & Black Surgical, Inc.

Black & Black Surgical, Inc.: FDA-registered device maker in Tucker, GA, United States, 11 510(k) clearances

Black & Black Surgical, Inc. is registered with the FDA (registration 3006142527) in Tucker, GA, United States. It lists 46 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 13, 2024. Registered through 2027. 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 Black & Black Surgical, Inc.
FDA registration number
3006142527
Address
5175 South Royal Atlanta Drive, Tucker, GA, United States, 30084
Owner or operator
BLACK & BLACK SURGICAL, INC. (9097380)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 22, 2012
Registered through
2027
Brand names listed
ASPIRATION TUBING, Arthroscope, BIPOLAR FORCEPS, Bottle, Collection, Vacuum, CALIPER, CLIQ ASPIRATOR DV-300, CLIQ ASPIRATOR DV-350, CURETTE and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Specification developeraccessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-PoweredJCX2Repackager or relabeleraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Specification developeraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Specification developeraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Specification developeraccessdata.fda.gov
ClampHXD1Specification developeraccessdata.fda.gov
Curette, EarJYG1Specification developeraccessdata.fda.gov
Curette, Surgical, General UseFZS1Specification developeraccessdata.fda.gov
Dilator, CatheterGCC1Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeler, Specification developeraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Specification developeraccessdata.fda.gov
Eye, Artificial, Non-CustomHQH1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Specification developeraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Specification developeraccessdata.fda.gov
HemostatHRQ1Specification developeraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Specification developeraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Knife, SurgicalEMF1Specification developeraccessdata.fda.gov
Light, Surgical HeadlightEBA1Repackager or relabeleraccessdata.fda.gov
Light, Surgical, FiberopticFST2Repackager or relabeleraccessdata.fda.gov
MalletHXL1Specification developeraccessdata.fda.gov
OsteotomeHWM1Specification developeraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Repackager or relabeleraccessdata.fda.gov
RaspHTR1Specification developeraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Specification developeraccessdata.fda.gov
RetractorGAD1Specification developeraccessdata.fda.gov
Retractor, FiberopticFDG1Specification developeraccessdata.fda.gov
RongeurHTX1Specification developeraccessdata.fda.gov
Saw, NasalKBC1Specification developeraccessdata.fda.gov
Scissors, General, SurgicalLRW1Specification developeraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Specification developeraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Specification developeraccessdata.fda.gov
System, Suction, Lipoplasty For RemovalQPB2Manufacturer, Specification developeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Specification developeraccessdata.fda.gov
Tube, Ear SuctionJZF1Specification developeraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Specification developeraccessdata.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
September 13, 2024K240188Vitruvian LiposaberQPBSubstantially EquivalentBlack & Black Surgical, Inc.accessdata.fda.gov
September 3, 2020K201203Cliq AspiratorBTASubstantially EquivalentAnest Iwata Sparmax Co., Ltd.accessdata.fda.gov
July 23, 2018K181398DV-300 AspiratorJCXSubstantially EquivalentDing Hwa Co., Ltd.accessdata.fda.gov
June 22, 2017K170629VITRUVIAN INFILTRATION PUMPQPBSubstantially EquivalentBlack & Black Surgical, Inc.accessdata.fda.gov
July 26, 2016K161722VITRUVIAN ULTIMATE ASPIRATORQPBSubstantially EquivalentBlack & Black Surgical, Inc.accessdata.fda.gov
July 30, 2014K132353SUCTION LIPOPLASTY ACCESSORIESQPBSubstantially EquivalentInexaccessdata.fda.gov
August 7, 2012K113795SUCTION LIPOLASTY ACCESSORIESQPBSubstantially EquivalentNorman M. Black Iiiaccessdata.fda.gov
January 18, 2008K072124BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODESGEISubstantially EquivalentBlack & Black Surgical, Inc.accessdata.fda.gov
July 29, 2005K051429CLARIS NON-STICK BIPOLAR FORCEPSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
February 1, 1995K943426ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPEHRXSubstantially EquivalentSchoelly Technologies, Inc.accessdata.fda.gov
April 23, 1990K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFSTSubstantially EquivalentCuda Products Co.accessdata.fda.gov

Compare with other makers

Updated September 13, 2024. 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.