Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

United States Endoscopy Group, Inc. — Predicate Candidate Screening

94 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time
222 days90th percentile
94clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192265gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc.2020-05-212741
K200745Lariat, Hot/Cold SnareUnited States Endoscopy Group, Inc.2020-04-21290
K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc.2019-09-17470
K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShiUnited States Endoscopy Group, Inc.2019-08-01490
K182909Roth Net Retriever Product LineUnited States Endoscopy Group, Inc.2018-11-21350
K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquUnited States Endoscopy Group, Inc.2018-09-21310
K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.2018-01-05380
K172805gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc.2017-10-23350
K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc.2017-03-10870
K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus RadiaUnited States Endoscopy Group, Inc.2017-01-06240
K153362AquaShield system CO2, AquaShield system-PENTAXUnited States Endoscopy Group, Inc.2015-12-16260
K152035iSnare system-LariatUnited States Endoscopy Group, Inc.2015-10-15850
K151345BioGuard Air/Water Valve, BioGuard Suction ValveUnited States Endoscopy Group, Inc.2015-08-25980
K151889Infinity ERCP Sampling DeviceUnited States Endoscopy Group, Inc.2015-07-30200
K151197Lariat snareUnited States Endoscopy Group, Inc.2015-07-06620
K140315US ENDOSCOPY DISTAL ATTACHMENT CAPUnited States Endoscopy Group, Inc.2014-04-04530
K140405TORRENT IRRIGATION SYSTEMUnited States Endoscopy Group, Inc.2014-03-12220
K131598ANAL RECTAL OVERTUBEUnited States Endoscopy Group, Inc.2014-02-262680
K133736ENDOSCOPIC SUTURE CUTTERUnited States Endoscopy Group, Inc.2014-01-07290
K133513MULTI-STAGE SNAREUnited States Endoscopy Group, Inc.2013-12-20380
K130148FOREIGN BODY HOODUnited States Endoscopy Group, Inc.2013-08-071970
K122462ROTH NET RETRIEVERUnited States Endoscopy Group, Inc.2012-09-11291
K120084ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.2012-05-301400
K112698CONCENTRIC BALLOON GOOGLEUnited States Endoscopy Group, Inc.2012-05-182450
K120123AQUASHIELD CO2 SYSTEMUnited States Endoscopy Group, Inc.2012-03-28710
K111028EUS BALLOONUnited States Endoscopy Group, Inc.2011-11-012020
K103694TISSUE SAMPLING NEEDLEUnited States Endoscopy Group, Inc.2011-07-272220
K103611UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTIONUnited States Endoscopy Group, Inc.2011-05-091510
K103326MULTIPLE BIOPSY SYSTEMUnited States Endoscopy Group, Inc.2011-04-061450
K103239IRRIGATION SYSTEMUnited States Endoscopy Group, Inc.2010-12-30581
K103437US ENDOSCOPY CYTOLOGY BRUSHUnited States Endoscopy Group, Inc.2010-12-23301
K101146WATER BOTTLE CAP SYSTEMUnited States Endoscopy Group, Inc.2010-07-16840
K100081ENTEROSCOPY OVERTUBE, MODEL 00712140United States Endoscopy Group, Inc.2010-04-12900
K092461IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 0United States Endoscopy Group, Inc.2009-11-05861
K092221COLONIC SPLINTING OVERTUBE, MODEL 00711145United States Endoscopy Group, Inc.2009-10-20900
K070420BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.2007-03-19271
K061201DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 0071United States Endoscopy Group, Inc.2006-05-30290
K051637DSNARE, MODEL 00711087United States Endoscopy Group, Inc.2005-10-311330
K040961INJECTOR NEEDLE/SNAREUnited States Endoscopy Group, Inc.2004-07-08860
K040494CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVEUnited States Endoscopy Group, Inc.2004-06-231180
K040836DISPOSABLE OVERTUBEUnited States Endoscopy Group, Inc.2004-06-10710
K984168BARRETT'S ESOPHAGEAL CYTOLOGY DEVICEUnited States Endoscopy Group, Inc.1999-12-073820
K972505RESUABLE HOT BIOPSY FORCEPSUnited States Endoscopy Group, Inc.1997-09-18770
K971842COAXIAL NEEDLEUnited States Endoscopy Group, Inc.1997-06-20321
K970945ANGLED TIP POLYPECTOMY SNAREUnited States Endoscopy Group, Inc.1997-05-07540
K963051ERCP CANNULAUnited States Endoscopy Group, Inc.1997-03-282340
K970356IRRIGATION/ASPIRATION POLYPECTOMYUnited States Endoscopy Group, Inc.1997-03-25540
K962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.1996-10-04872
K962346PAPILLOTOMEUnited States Endoscopy Group, Inc.1996-08-08510
K961762REUSABLE ENDOSCOPIC ACCESSORY HANDLEUnited States Endoscopy Group, Inc.1996-07-22760

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda