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

Endoscopic Access Overtube, Gastroenterology-Urology

Regulation 876.1500

6510(k)s in 12 months (105 all time)
0recalls in 12 months (12 all time)
9recalls that name a 510(k)
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Top companies in FED

Company510(k)sRecalls
Boston Scientific73
Usgi Medical60
Boddingtons Plastics, Ltd.41
C.R. Bard, Inc.50
Neptune Medical, Inc.50
Trokamed GmbH14
Coloplast A/S40
United States Endoscopy Group, Inc.40
Applied Medical Resources30
Calyxo, Inc.21
Decided510(k)Device and applicantCode
Sep 21, 2026K260512Disposable Ureteral Access Sheath
Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN
FED
Sep 18, 2026K262262Pathfinder Endoscope Overtube
Neptune Medical, Inc.
FED
Sep 11, 2026K260410Single Use Ureteral Access Sheath
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
FED
Aug 4, 2026K261915Navigator™ Flex Ureteral Access Sheath Set
Boston Scientific Corporation
FED
Apr 13, 2026K260965CVAC Aspiration System
Calyxo, Inc.
FED
Apr 6, 2026K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
Zhuhai Pusen Medical Technology Co., Ltd., CN
FED
Oct 7, 2025K252572Prodeon Urethral Sheath System
Prodeon Medical, Inc.
FED
Sep 19, 2025K250128Single Use Suction-Evacuation Ureteral Access Sheath
Anhui Happiness Workshop Medical Instruments Co., Ltd., CN
FED
Sep 5, 2025K250132Ureteral Access Sheath
Zhejiang YiGao Medical Technology Co., Ltd., CN
FED
Jul 8, 2025K250695Single-use Ureteral Access Sheath
Shenzhen HugeMed Medical Technical Development Co., Ltd., CN
FED
Jul 3, 2025K251599Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd., CN
FED
Jun 27, 2025K250585LumenaTM Ureteral Access Sheath
Cathegenix (Xiamen) Co., Ltd., CN
FED
Jun 2, 2025K250452CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0
MacroLux Medical Technology Co., Ltd., CN
FED
Apr 11, 2025K243710Disposable ureteral access sheath
Shenzhen Trious Medical Technology Co., Ltd., CN
FED
Mar 21, 2025K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F
Boston Scientific Corporation
FED
Jan 31, 2025K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IV
Dornier Medtech America
FED
Jan 30, 2025K243025Ureteral Access Sheath
Seplou (Zhuhai) Co., Ltd., CN
FED
Nov 12, 2024K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
Coloplast Corp.
FED
Nov 1, 2024K243091Over-tube (TR-1108A)
Fujifilm Corporation, JP
FED
Oct 8, 2024K240167Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd., CN
FED
Aug 2, 2024K241181Disposable Ureteral Guide Sheath
Dongguan Zsr Biomedical Technology Company Limited, CN
FED
Jun 27, 2024K240853Pathfinder® CR System
Neptune Medical, Inc.
FED
Feb 2, 2024K233472CVAC Aspiration System + CVAC Image Processor
Calyxo, Inc.
FED
Sep 15, 2023K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
FUJIFILM Healthcare Americas Corporation
FED
Aug 2, 2023K230748Disposable Ureteral Access Sheath
Youcare Technology Co.,Ltd. (Wuhan), CN
FED
Jul 28, 2023K230801Pathfinder Endoscope Overtube with Balloon Device
Neptune Medical, Inc.
FED
May 25, 2022K220065Single Use Ureteral Access Sheath
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
FED
Jul 30, 2021K200770Mini PCNL-System
Trokamed GmbH, DE
FED
May 28, 2021K211301Pathfinder Endoscope Overtube
Neptune Medical, Inc.
FED
Apr 30, 2021K203165Disposable Ureteral Access Sheath
Suzhou Beyo Medical Technology Co., Ltd., CN
FED
Dec 9, 2020K203119ClearPetra Suction-Evacuation Sheath
Well Lead Medical Co., Ltd., CN
FED
Nov 20, 2020K201815Dornier MAGELLAN Ureteral Access Sheath
Dornier Medtech America, Inc.
FED
May 22, 2020K200419Kalera Vacuum Aspiration Catheter (K-VAC)
Kalera Medical, Inc.
FED
Feb 21, 2020K192691PatCom Single-Use Introducer
H&A Mui Enterprises, Inc., CA
FED
Aug 30, 2019K191415Pathfinder Endoscope Overtube
Neptune Medical, Inc.
FED
May 30, 2019K191067Arc Endocuff Glide AEG110 & AEG120
Boddingtons Plastics, Ltd., GB
FED
May 29, 2019K182403Peel-Away Introducer
Cook Incorporated
FED
May 15, 2019K182520Flexible Overtube
Sumitomo Bakelite Co., Ltd., JP
FED
Mar 5, 2019K190030Embrella Endoscopic Distal Attachment
Micro-Tech (Nanjing) Co., Ltd., CN
FED
Sep 7, 2018K181811ReTrace Ureteral Access Sheath
Coloplast A/S
FED
Feb 9, 2018K173400ORISE Tissue Retractor System
Boston Scientific
FED
Feb 5, 2018K171208Trans-anal Introducer
Visionsense, Ltd., IL
FED
Jan 18, 2018K172575BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
Baronova, Inc.
FED
Dec 13, 2017K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
Cook Incorporated
FED
Dec 9, 2016K162205Arc EndoCuff and Arc EndoCuff Vision
Boddingtons Plastics, Ltd., GB
FED
Oct 12, 2016K161110ClearPetra Suction-Evacuation Sheath
Well Lead Medical Co., Ltd., CN
FED
Jul 14, 2016K160846AmplifEYE
Medivators, Inc.
FED
Mar 31, 2016K160861Proxis Ureteral Access Sheath
C.R. Bard, Inc.
FED
Jan 7, 2016K151084Well Lead Ureteral Access Sheath
Well Lead Medical Co., Ltd., CN
FED
Aug 13, 2015K151801Arc Endocuff Vision
Boddingtons Plastics, Ltd., GB
FED

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