Atlas FDA

FED

101 FDA 510(k) clearances · Product code

91 daysmedian time to decision
244 days90th percentile
101clearances measured

FDA profile

Official device name
Endoscopic Access Overtube, Gastroenterology-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Adverse events (MAUDE)
2021: 55 · 2022: 36 · 2023: 53 · 2024: 64 · 2025: 117 · 2026: 56
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CVAC Aspiration System (K260965)Calyxo, Inc.2026-04-13
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (K260521)Zhuhai Pusen Medical Technology Co., Ltd.2026-04-06
Prodeon Urethral Sheath System (K252572)Prodeon Medical, Inc.2025-10-07
Single Use Suction-Evacuation Ureteral Access Sheath (K250128)Anhui Happiness Workshop Medical Instruments Co., Ltd.2025-09-19
Ureteral Access Sheath (K250132)Zhejiang YiGao Medical Technology Co., Ltd.2025-09-05
Single-use Ureteral Access Sheath (K250695)Shenzhen HugeMed Medical Technical Development Co., Ltd.2025-07-08
Single-use Ureteral Access Sheath (K251599)Hunan Vathin Medical Instrument Co., Ltd.2025-07-03
LumenaTM Ureteral Access Sheath (K250585)Cathegenix (Xiamen) Co., Ltd.2025-06-27
CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) (K250452)MacroLux Medical Technology Co., Ltd.2025-06-02
Disposable ureteral access sheath (K243710)Shenzhen Trious Medical Technology Co., Ltd.2025-04-11
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (K250517)Boston Scientific Corporation2025-03-21
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (K243820)Dornier Medtech America2025-01-31
Ureteral Access Sheath (K243025)Seplou (Zhuhai) Co., Ltd.2025-01-30
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (K242173)Coloplast Corp.2024-11-12
Over-tube (TR-1108A) (K243091)Fujifilm Corporation2024-11-01
Single-use Ureteral Access Sheath (K240167)Hunan Vathin Medical Instrument Co., Ltd.2024-10-08
Disposable Ureteral Guide Sheath (K241181)Dongguan Zsr Biomedical Technology Company Limited2024-08-02
Pathfinder® CR System (K240853)Neptune Medical, Inc.2024-06-27
CVAC Aspiration System + CVAC Image Processor (K233472)Calyxo, Inc.2024-02-02
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (K230752)FUJIFILM Healthcare Americas Corporation2023-09-15
Disposable Ureteral Access Sheath (K230748)Youcare Technology Co.,Ltd. (Wuhan)2023-08-02
Pathfinder Endoscope Overtube with Balloon Device (K230801)Neptune Medical, Inc.2023-07-28
Single Use Ureteral Access Sheath (K220065)Zhejiang Chuangxiang Medical Technology Co., Ltd.2022-05-25
Mini PCNL-System (K200770)Trokamed GmbH2021-07-30
Pathfinder Endoscope Overtube (K211301)Neptune Medical, Inc.2021-05-28
Disposable Ureteral Access Sheath (K203165)Suzhou Beyo Medical Technology Co., Ltd.2021-04-30
ClearPetra Suction-Evacuation Sheath (K203119)Well Lead Medical Co., Ltd.2020-12-09
Dornier MAGELLAN Ureteral Access Sheath (K201815)Dornier Medtech America, Inc.2020-11-20
Kalera Vacuum Aspiration Catheter (K-VAC) (K200419)Kalera Medical, Inc.2020-05-22
PatCom Single-Use Introducer (K192691)H&A Mui Enterprises, Inc.2020-02-21
Pathfinder Endoscope Overtube (K191415)Neptune Medical, Inc.2019-08-30
Arc Endocuff Glide AEG110 & AEG120 (K191067)Boddingtons Plastics, Ltd.2019-05-30
Peel-Away Introducer (K182403)Cook Incorporated2019-05-29
Flexible Overtube (K182520)Sumitomo Bakelite Co., Ltd.2019-05-15
Embrella Endoscopic Distal Attachment (K190030)Micro-Tech (Nanjing) Co., Ltd.2019-03-05
ReTrace Ureteral Access Sheath (K181811)Coloplast A/S2018-09-07
ORISE Tissue Retractor System (K173400)Boston Scientific2018-02-09
Trans-anal Introducer (K171208)Visionsense, Ltd.2018-02-05
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap (K172575)Baronova, Inc.2018-01-18
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath (K172217)Cook Incorporated2017-12-13
Arc EndoCuff and Arc EndoCuff Vision (K162205)Boddingtons Plastics, Ltd.2016-12-09
ClearPetra Suction-Evacuation Sheath (K161110)Well Lead Medical Co., Ltd.2016-10-12
AmplifEYE (K160846)Medivators, Inc.2016-07-14
Proxis Ureteral Access Sheath (K160861)C.R. Bard, Inc.2016-03-31
Well Lead Ureteral Access Sheath (K151084)Well Lead Medical Co., Ltd.2016-01-07
Arc Endocuff Vision (K151801)Boddingtons Plastics, Ltd.2015-08-13
Sidecar External Working Channel (K150083)C2 Therapeutics2015-04-14
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM (K140523)Coloplast A/S2014-07-24
NAVIGATOR HD URETERAL ACCESS SHEATH SETS (K140323)Boston Scientific2014-03-07
ANAL RECTAL OVERTUBE (K131598)United States Endoscopy Group, Inc.2014-02-26
ENDORINGS (K133359)Endo-Aid, Inc.2014-02-11
ENDOSCOPIC INTRODUCER (K123013)Novadaq Technologies, Inc.2013-03-22
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR (K123675)Coloplast A/S2013-03-01
NAVIGATOR HD URETERAL ACCESS SHEATH SET (K122649)Boston Scientific Corp2012-12-12
OVERTUBE ENDOSCOPIC ACCESS SYSTEM (K122270)Apollo Endosurgery, Inc.2012-09-28
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE (K120126)Barosense, Inc.2012-09-10
ARC ENDOCUFF (K122565)Boddingtons Plastics, Ltd.2012-09-04
ENDOFLIP ECD (K110531)Crospon, Ltd.2011-10-06
RE-TRACE URETERAL ACCESS SHEATH (K102485)Coloplast A/S2010-10-18
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 (K082102)Apollo Endosurgery, Inc.2010-06-14
ENTEROSCOPY OVERTUBE, MODEL 00712140 (K100081)United States Endoscopy Group, Inc.2010-04-12
COLONIC SPLINTING OVERTUBE, MODEL 00711145 (K092221)United States Endoscopy Group, Inc.2009-10-20
CAD 12, COLONOSCOPY ASSIST DEVICE (K092156)Softscope Medical Technologies, Inc.2009-10-14
FUJINON STERILE OVERTUBES (K091773)Fujinon, Inc.2009-08-07
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 (K082589)Barosense, Inc.2009-05-22
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE (K080050)Spirus Medical, Inc.2008-05-06
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (K072405)Usgi Medical2007-09-13
MODIFICATION TO ENDO-EASE (K062805)Spirus Medical, Inc.2006-10-13
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 (K061324)Rtc Inc.-Memcath Technologies, LLC2006-06-20
USGI TRANSPORT ENDOSCOPIC GUIDE (K061216)Usgi Medical2006-05-15
ENDO-EASE ENDOSCOPIC OVERTUBE (K052084)Spirus Medical, Inc.2005-09-14
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE (K051919)Usgi Medical2005-07-26
SPYSCOPE ACCESS AND DELIVERY CATHETER (K051504)Boston Scientific Corp2005-06-16
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH (K043418)Cook Urological, Inc.2005-03-31
USGI SHAPELOCK ENDOSCOPIC GUIDE (K050253)Usgi Medical2005-02-28
DISPOSABLE OVERTUBE (K040836)United States Endoscopy Group, Inc.2004-06-10
SHAPE LOCKING ENDOSCOPIC OVERTUBE (K033954)Usgi Medical, Inc.2004-03-19
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT (K033778)C.R. Bard, Inc.2003-12-30
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE (K023902)Usgi Medical, Inc.2003-08-20
DEFLECTING URETERAL ACCESS SHEATH (K030642)Applied Medical Resources Corp.2003-05-23
NAVIGATOR URETERAL ACCESS SHEATH SET (K030956)Boston Scientific Corp2003-05-23
BARD AQUAGUIDE URETERAL CONDUIT (K030438)C.R. Bard, Inc.2003-03-17
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE (K022686)Lap Surgical Systems, LLC2002-11-25
NDO SURGICAL SURGICAL OVERTUBE (K002018)Surgical, Inc.2000-08-17
URETERAL ACCESS SHEATH SET - NEW MODELS (K993650)Applied Medical Resources1999-12-28
URETERAL ACCESS SHEATH SET (K990775)Applied Medical Resources1999-04-21
DELIVERY SHEATH (K983415)Conway Stuart Medical, Inc.1998-12-01
BARD ENDOSCOPIC OVERTUBE (#000307) (K973500)C.R. Bard, Inc.1997-10-16
OT-1 (K972781)Prism Therapeutics, LLC1997-09-19
COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH (K942573)Richard Hamer Assoc., Inc.1994-07-18
BARD ENDOSCOPIC OVERTUBE (K942044)C.R. Bard, Inc.1994-06-10
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER (K921120)Cook Urological, Inc.1992-08-04
MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (K912265)Medical Laser, Inc.1991-10-10
ST-E1 OVERTUBE (K903842)Olympus Corp.1991-01-23
PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. (K896680)Interson Corp.1990-02-14
ESOPHAGEAL OVERTUBE (K890629)Gastrotech, Inc.1989-05-31
FOREIGN BODY PROTECTOR (K841258)Jayco Pharmaceuticals1984-07-09
ENDOSCOPIC OVERTUBE (K833268)Mill-Rose Laboratory1983-10-31
SPLIT COLON STIFFENING TUBE (K830247)Keymed, Inc.1983-03-15
KEY MED FOREIGN BODY REMOVAL TUBE (K813325)Keymed, Inc.1982-02-10
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Every clearance here is in the API, with alerts when new ones post.