Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005099803

FEI Number

3005099803

Entity Name

BOSTON SCIENTIFIC CORPORATION

City/State/Country

Marlborough, MA, US

Establishment Address

100 BOSTON SCIENTIFIC WAY, Marlborough, MA 01752, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Boston Scientific Corporation (Owner Number: 9912058)

Owner / Operator Contact Address

300 Boston Scientific Way, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231533

PMA Number

N/A

All Registered Proprietary Names

Flexima Nephrostomy Catheter System Kit Flexima Nephrostomy Catheter System TLA Introducer Needle and Sheath Set Percutaneous Access Needle Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit Malecot Nephrostomy Catheter Set Flexima Nephrostomy Catheter System Kit with Dissolving Tip Flexima Nephrostomy Catheter System with Dissolving Tip JINRO Pigtail Nephrostomy Catheter Kit Percuflex Locking Loop Nephrostomy Catheter with Fader Tip Re-entry Malecot Nephrostomy Catheter Set Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Percutaneous Access Needle with Echogenic Tip JINRO Pigtail Nephrostomy Catheter Placement Kit JINRO Pigtail Nephrostomy Catheter Percuflex Locking Loop Nephrostomy Catheter VTC Nephrostomy Catheters System Kit VTC Nephrostomy Catheters System Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit Percutaneous Access Set NaviGuide Percutaneous Access Needle Stone Cone Nitinol Urological Retrieval Coil Urovac Bladder Evacuator Alair RF Controller Accessory Kit Alair Bronchial Thermoplasty Controller Alair Bronchial Thermoplasty Catheter Ureteral Stent Positioners Pneumatic Inflator Trapezoid RX Wireguided Retrieval Basket AMS 800 with Inhibizone AMS 800 without Inhibizone

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2017-03-29
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-01-20
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2023-01-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-12-22
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-12-17
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-17
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-02
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-05-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-12-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-12-04
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2020-12-04
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-14
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-05-03
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-07-21
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2021-03-16
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-08-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-08-14
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1997-10-20
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2008-01-03
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2008-01-14
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-05-27
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2020-05-27
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2020-05-27
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-09-06
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2010-09-09
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2015-03-31
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-11-25
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-14
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-08-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-04-18
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2023-06-20
QTD	Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	Gastroenterology, Urology	Class 2	876.5983	2023-10-16
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-05-01
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2001-10-11
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2013-03-17
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-08-30
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-12-23
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2016-12-23
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-01-03
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1992-07-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
PWI	Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse	Obstetrics/Gynecology	Class 2	884.4910	2018-03-09
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2021-12-16
FGD	Catheter, Retention, Barium Enema With Bag	Gastroenterology, Urology	Class 2	876.5980	2025-03-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-03
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2011-12-09
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2014-07-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2008-01-03
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2026-03-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-14
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2018-05-31
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-01-14
BWH	Forceps, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2012-12-10
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2014-10-21
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2025-05-30
BTG	Brush, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-01-14
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2018-11-28
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-14
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2008-01-14
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2008-01-14
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2008-01-14
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2008-01-14
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2010-12-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-12-14
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-05-03
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-05-03
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2014-02-05
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-01-23
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2026-01-06
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-06
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2021-05-26
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2002-01-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-10-28
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-08-03
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2018-02-09
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2008-12-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-08-25
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2016-12-20
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-14
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2016-04-26
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2010-09-15
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-08-01
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2016-12-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-12-22
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2023-07-15
NWT	Endoscopic Cholangiogram Kit	Gastroenterology, Urology	Class 2	876.1500	2013-08-12
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-05-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2016-05-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-21
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2008-11-05
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2016-12-23
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	1992-07-22
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2002-09-12
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2014-06-16
QTD	Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	Gastroenterology, Urology	Class 2	876.5983	2023-05-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-08-25
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2019-07-11
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2022-05-12
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2025-05-30
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2018-05-24
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2016-12-22
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2008-01-03
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-01-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-14
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-11-25
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-04-24
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-04-24
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2014-04-24
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2008-01-03
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-01-03
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2016-12-23
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-12-31
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-11-14
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2008-01-14
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2008-01-14
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2016-12-05
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2024-12-17
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2018-01-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-03-06
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-03-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-03-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-03-06
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2013-07-02
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2019-03-06
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-01-30
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-05-29
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2016-05-20
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2016-05-20
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2004-09-13
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	1992-07-22
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-22
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2024-06-13
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2008-01-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-14
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-12-12
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-02-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-02-06
OOY	Bronchial Thermoplasty System	Unknown	Class 3	N/A	2010-10-29
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-10-13
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2019-01-25
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2019-01-25
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-01-25
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2003-06-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-08-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2008-01-14
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-05-03
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2008-01-03
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-08-22
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2008-01-15
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	General, Plastic Surgery	Class 2	878.3300	2008-12-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-14
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-12-22
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2002-09-12
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2021-05-03
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2025-12-02
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2025-12-02
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-03-12
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-14
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2024-05-02
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-05-08
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2011-12-12
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-12-12
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2019-08-29
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-12-22
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	Class 2	876.4500	2016-12-05
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2022-03-10
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2008-01-14
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-02-09
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
EZY	Device, Incontinence, Mechanical/Hydraulic	Gastroenterology, Urology	Class 3	876.5280	2015-10-06
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2018-05-31
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-03-26
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-05-08
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2003-04-24
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2021-06-02
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-07-13

Official Correspondent

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US Agent Details

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Same Entity

Boston Scientific Corporation

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025434462	Obsidio Inc	Maple Grove, MN, US
3005619880	Boston Scientific Corporation	Roswell, GA, US
3015425075	NALU MEDICAL	Carlsbad, CA, US
3015289131	FARAPULSE, INC.	Menlo Park, CA, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3004065885	Creation Technologies	Everett, WA, US
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
3015970743	CENTERPOINT SYSTEMS LLC	West Valley City, UT, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005099803. Last updated year: 2026. Please use registration number 3005099803 when referencing this establishment in official correspondence.