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)
Top companies in FBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Aomori Olympus Co., Ltd. | 0 | 20 |
| Hobbs Medical, Inc. | 0 | 15 |
| Boston Scientific Corp | 4 | 3 |
| Carbon Medical Technologies, Inc. | 5 | 0 |
| Wilson-Cook Medical, Inc. | 4 | 1 |
| Advanced Uroscience, Inc. | 3 | 0 |
| Enteric Medical Technologies | 3 | 0 |
| Mill-Rose Laboratory | 3 | 0 |
| Olympus Medical Systems Corp. | 3 | 0 |
| Uroplasty, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Cook 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 |
FBK | K171602 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 Open, Classified |
FBK | K834403 |
| Nov 15, 2024 | Hobbs Medical, Inc. Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 Open, Classified |
FBK | K834403 |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A Open, Classified |
FBK | K950976 |
| Apr 28, 2023 | Labories Medical Technologies injeTAK Adjustable Tip Needles
Needle Sheath diameter 6Fr with 35-50cm in length
Stainless-stell needle cannula is 25 gauge Open, Classified |
FBK | K090830 |
| Nov 11, 2022 | Boston 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 |
FBK | K171454 |
| Nov 11, 2022 | Boston 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 |
FBK | K171454 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Posi-Stop Injection Needle
Catalog Number: 4722 Open, Classified |
FBK | None listed |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Posi-Stop Injection Needle
Catalog Number: 4720 Open, Classified |
FBK | None listed |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Posi-Stop Injection Needle
Catalog Number: 4718 Open, Classified |
FBK | None listed |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Posi-Stop Injection Needle
Catalog Number: 4712 Open, Classified |
FBK | None listed |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Posi-Stop Injection Needle
Catalog Number: 4704 Open, Classified |
FBK | K834403 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Posi-Stop Injection Needle
Catalog Number: 4702 Open, Classified |
FBK | K834403 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jan 4, 2021 | Aomori 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 |
FBK | K153625 |
| Jun 14, 2019 | Wilson-Cook Medical Inc. Acuject Variable Injection Needle Terminated |
FBK | K941305 |
| Oct 19, 2016 | US 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 |
FBK | K971842 |
| Oct 28, 2005 | Boston Scientific Corporation Enteryx Injector Single Pack
Order Number: M00572650-US and M00572630 -OUS Terminated |
FBK | None listed |
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