IVUS ILAC SANAYI VE TICARET AS

FDA Device Registration & Listing · Istanbul, TR · Registration 3021632375

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021632375
FEI Number
3021632375
Entity Name
IVUS ILAC SANAYI VE TICARET AS
City/State/Country
Istanbul, TR
Establishment Address
Yesilkoy cad. No 25 Florya Bakirkoy, Istanbul 34153, TR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
IVUS ILAC SANAYI VE TICARET AS (Owner Number: 10084070)
Owner / Operator Contact Address
Yesilkoy cad. No 25 Florya Bakirkoy, Istanbul, TR-34 34153, TR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140879
PMA Number
N/A

All Registered Proprietary Names

MD MD MD MD MD P MD MD MD MD MD MD MD MD MD MD MD MD MD BXT B MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD MD CVT MD MD P MD MD MD STR MD MD MD MD MD MD MD MD MD MD MD MD MD MD

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2023-06-22
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2022-09-30
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2022-09-30
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2022-09-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-03-29
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2022-10-08
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2026-03-03
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2022-10-24
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2023-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-04-14
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2026-06-16
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2022-02-15
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2022-02-15
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2022-02-15
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2022-02-15
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-06-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-03-03
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-03-14
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2022-08-09
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2022-08-09
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2022-03-24
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-01-20
MON System, Hemodialysis, Remote Accessories Gastroenterology, Urology Class 1 876.5820 2026-03-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-10-24
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-04-14
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2022-10-24
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2022-02-22
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-02-15
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2026-01-15
GAG Stapler, Surgical General Hospital Class 2 878.4740 2026-01-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-01-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-08-23
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2023-11-14
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2023-11-14
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling General, Plastic Surgery Class 2 878.3300 2023-06-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-12-19
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2022-12-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-02-15
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2023-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-02-15
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-05-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-03-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-02-15
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-09-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-06-22
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2022-09-30
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2023-01-10
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2022-09-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-06-13
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2025-11-25
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2022-09-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-03-14
DQA Oximeter Cardiovascular Class 2 870.2700 2026-03-03
GAG Stapler, Surgical General Hospital Class 2 878.4740 2022-01-14
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2022-01-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-03-14
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2022-08-10
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2022-08-10
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2025-08-21
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-08-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-02-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-02-15
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-03-29
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-01-10
GCI Laryngoscope, Endoscope Gastroenterology, Urology Class 2 876.1500 2022-10-09
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-03-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-09-16
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2023-03-14
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2023-03-14
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2022-09-23
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2022-10-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-04-25
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2025-04-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-03-29

Official Correspondent

Abuzer Tandogan

US Agent Details

Abuzer Tandogan Business: IVUS MEDICAL SUPPLY Email: info@ivushealth.com Phone: (202) 9938601

Related Public Records

Same Entity

IVUS ILAC SANAYI VE TICARET AS
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
K082659 Covidien Lp, Formerly Registered AS United States MODIFIED ENDO STICH 2008-09-19
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22
K130717 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RELOAD 2013-04-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021 N/A 2
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021632375. Last updated year: 2026. Please use registration number 3021632375 when referencing this establishment in official correspondence.
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