Atlas FDA

MND

15 FDA 510(k) clearances · Product code

87 daysmedian time to decision
286 days90th percentile
15clearances measured

FDA profile

Official device name
Ligator, Esophageal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4400
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 674 · 2022: 808 · 2023: 689 · 2024: 921 · 2025: 1,098 · 2026: 497
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AUTOBAND LIGATOR (K132535)Endochoice, Inc.2013-08-23
MODIFICATION TO AUTO-BAND LIGATOR (K083556)Scandimed International2009-02-19
AUTO-BAND LIGATOR (K081142)Scandimed International2008-05-16
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (K051950)Ethicon Endo-Surgery, Inc.2005-10-07
AUTO-BAND LIGATOR (K031236)Scandimed. A.S.2003-11-14
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K033245)C.R. Bard, Inc.2003-11-06
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K022434)C.R. Bard, Inc.2002-08-05
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K013066)Olympus America, Inc.2001-12-11
OLYMPUS ENDOSCOPIC LIGATION DEVICE (K001744)Olympus America, Inc.2001-02-27
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (K990864)Boston Scientific Corp1999-06-11
OLYMPUS HX-20 SERIES LIGATING DEVICE (K984255)Olympus Corp of America1999-01-12
HX-20/21-1 ENDOSCOPIC LIGATOR (K964661)Olympus America, Inc.1997-10-30
BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137)C.R. Bard, Inc.1997-10-16
WILSON COOK MULTIPLE BAND LIGATOR (K944220)Wilson-Cook Medical, Inc.1995-01-24
STIEGMANN-GOFF ENDOSCOPIC LIGATOR (K940661)C.R. Bard, Inc.1994-11-28

Track MND automatically

Every clearance here is in the API, with alerts when new ones post.