Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006142527

FEI Number

3006142527

Entity Name

BLACK & BLACK SURGICAL, INC.

City/State/Country

Tucker, GA, US

Establishment Address

5175 South Royal Atlanta Drive, Tucker, GA 30084, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BLACK & BLACK SURGICAL, INC. (Owner Number: 9097380)

Owner / Operator Contact Address

5175 South Royal Atlanta Drive, Tucker, GA 30084, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EAR SUCTION TUBES EAR LOOP Surgical Instrument Tray Fiber Optic Retractor Electrosurgical Forceps and Electrodes LUER TO LUER CONNECTOR Vitruvian Ultimate Aspirator Rasp Tubing INFILTRATION TUBING Rongeur EYE SHIELD Knife RONGUER Bottle, Collection, Vacuum Vitruvian Infiltration Pump Headlight retractor NASAL Scissors Needle Holder Fiber Optic adaptor ruler, calipers, markers Hemostat Arthroscope CLIQ ASPIRATOR DV-300 DISPOSABLE CANNULAS reusable cannula and injection cannula/needles Speculum Osteotome Clip Applier Dissectors PROBE BIPOLAR FORCEPS FORCEPS Fiber Optic Cables CALIPER VITRUVIAN LIPOSABER Handle, Scalpel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2022-05-27
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-05-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-26
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2015-03-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-26
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-04-02
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2016-11-10
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-02-26
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2013-06-07
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2013-02-26
HQH	Eye, Artificial, Non-Custom	Ophthalmic	Class 1	886.3200	2022-05-27
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-26
HTX	Rongeur	Orthopedic	Class 1	888.4540	2017-06-19
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2013-09-13
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2017-06-26
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2013-08-15
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-02-26
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2017-06-21
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-26
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2013-02-26
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2013-12-17
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-02-26
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2013-02-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-06-05
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2021-07-30
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2020-03-12
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2012-10-22
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2013-02-26
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-02-26
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2013-02-26
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-26
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-02-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-24
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2017-06-21
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2016-06-24
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-05-27
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2025-12-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-02-26

Official Correspondent

NORMAN BLACK, III

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BLACK & BLACK SURGICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

Similar Registrations

Registration Number	Establishment Name	Location
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8010890	PETER LAZIC GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3006098219	ADEPT MEDICAL LTD	AUCKLAND, NZ
3008770252	NOVO SURGICAL, INC.	Westmont, IL, US
3002808270	USTOMED INSTRUMENTE GMBH & CO. KG	Tuttlingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006142527. Last updated year: 2026. Please use registration number 3006142527 when referencing this establishment in official correspondence.