ClearanceBrief
Panels › Gastroenterology, Urology › Product code FBK · Class 2

Endoscopic Injection Needle, Gastroenterology-Urology

Regulation 876.1500

3510(k)s in 12 months (89 all time)
1recalls in 12 months (43 all time)
38recalls that name a 510(k)
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Top companies in FBK

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Cook Incorporated
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112
Open, Classified
FBKK171602
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Open, Classified
FBKK834403
Nov 15, 2024Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Open, Classified
FBKK834403
Dec 18, 2023Karl Storz Endoscopy
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Open, Classified
FBKK950976
Apr 28, 2023Labories Medical Technologies
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Open, Classified
FBKK090830
Nov 11, 2022Boston Scientific Corporation
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prio
Open, Classified
FBKK171454
Nov 11, 2022Boston Scientific Corporation
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal muco
Open, Classified
FBKK171454
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4722
Open, Classified
FBKNone listed
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4720
Open, Classified
FBKNone listed
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Open, Classified
FBKNone listed
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Open, Classified
FBKNone listed
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Open, Classified
FBKK834403
Oct 7, 2022Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Open, Classified
FBKK834403
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jan 4, 2021Aomori Olympus Co., Ltd.
NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Terminated
FBKK153625
Jun 14, 2019Wilson-Cook Medical Inc.
Acuject Variable Injection Needle
Terminated
FBKK941305
Oct 19, 2016US Endoscopy Group Inc
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flex
Terminated
FBKK971842
Oct 28, 2005Boston Scientific Corporation
Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS
Terminated
FBKNone listed

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