Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014461810

FEI Number

3014461810

Entity Name

BURAK GLOBAL IC VE DIS TIC LTD STI

City/State/Country

Kocasinan Kayseri, TR

Establishment Address

Sahabiye Mh. Ahmet Pasa Cd., Ahmet Pasa Is Merk. No: 16/701, Kocasinan Kayseri 38015, TR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

BURAK GLOBAL IC VE DIS TIC LTD STI (Owner Number: 10058392)

Owner / Operator Contact Address

Sahabiye Mh. Ahmet Pasa Cd., Ahmet Pasa Is Merk. No: 16/701, Kocasinan, TR-38 38015, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113268

PMA Number

N/A

All Registered Proprietary Names

MCM20 Endo Stitch COMPOSITE MESH Ligasure Blunt Tip, Sealer/Divider, Nano-Coated Ligaclip Brain Monitoring Sensor Z304H & Z305H sutures LigaSure Maryland Jaw Sealer/Divider One-Step Sealing, Nano-Coated ENDO CLIP III5MM CLIP ADAPTER 120MM SURGINEEDLE INSUFFLATION NEEDLE polypropylene suture AQ Foam Adhesive Remover Spray Abstack30 MCP317H SR75 Open Fusion Laparoscopic Device AG SCD DRS Mesh Trach Tube Hemolok clip PREPERITONEAL DISTENTION BALLOON SYSTEM ENDOPATH Trocar Covidien EEA Stapler VERSAPORT V2 BLADELESS OPTIICAL TROCAR NC Trek Rx HI-TORQUE WHISPER ES GUIDE WIRE Endoscopic Linear Cutter EGIA Universal; Stapler PSD4506ECHV RETRIEVAL SYSTEM Pro Tack Fixation 5 mm Low Pressure Cuffed Trach Tube curved stapler Access and Dissector System Kii Balloon BluntTip 8556H DEFIBRILLATION LEAD Ethicon Clip Applier ONB Trocar Hemorrhoid and Prolapse Stapler Premium Plus CEEA Hemostat Flour Distal Access Catherer Vesaport Insufflation Needle SECURESTRAP 770G Analog Inflation Syringe SPACEMAKER SBT 10MM Guide wire Ligating Loop ONB Trocars Spacemaker Plus 2MM DILATOR & CANNULA ENDO CATCH GOLD 10MM HARH36 Bard Mesh SorbaFix and PermaFix Absorbable Fixation Systems Endoscopic Clamp V549G Wond Protector Surgical Mesh NC Trek Y493G 176645 Bard Arista AH 3g HARMONIC ACE LAPAROSCOPIC SHEARS 176643 EB230

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-03-28
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2020-02-05
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2023-04-10
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-04-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-05-29
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-11-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2021-09-27
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2021-09-27
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2021-09-27
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2021-09-27
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2019-06-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-26
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2021-02-09
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-02-09
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2021-02-09
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2023-05-02
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2025-08-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-02-05
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-03-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-06-26
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2019-03-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-02-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-08-14
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2025-05-01
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-02-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-10-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-10-08
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-09-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-09-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-05-29
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2024-03-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-03-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-03-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-08-06
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-05-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-07-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-06-16
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2021-06-16
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2024-11-05
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2025-05-01
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-08-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-09-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2019-03-26
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2023-05-08
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2023-05-08
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-09-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-05-23
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Gastroenterology, Urology	Class 2	876.1500	2019-05-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-03-04
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2022-12-28
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-02-05
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2024-07-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-03-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-03-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-08-18
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2025-08-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-08-23
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2019-03-26
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2019-03-26
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2019-03-26
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2019-03-26
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2019-03-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-03-26
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2019-03-26
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2024-09-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-07-05
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2026-05-18
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2026-05-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-06-04
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2022-09-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-05-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-05-16
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2021-03-09
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-03-28
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-03-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-05-13
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2019-10-18
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2019-03-26
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2024-11-05
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2024-08-19
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2024-08-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-08-14
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2024-02-05
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2019-04-08
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2020-02-04
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2019-05-29
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-03-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-02-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2024-11-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-08-24
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2022-12-28

Official Correspondent

Hayati ERTUGRUL

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

BURAK GLOBAL IC VE DIS TIC LTD STI

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
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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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014461810. Last updated year: 2026. Please use registration number 3014461810 when referencing this establishment in official correspondence.