Atlas FDA

LJH

28 FDA 510(k) clearances · Product code

90 daysmedian time to decision
265 days90th percentile
28clearances measured

FDA profile

Official device name
System, Irrigation, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 23 · 2021: 15 · 2022: 21 · 2023: 34 · 2025: 25 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Karl Storz UROMAT E.A.S.I. (K162992)Karl Storz Endoscopy America, Inc.2017-07-07
AMSURE BLADDER IRRIGATION SET (K070873)Amsino Intl., Inc.2007-12-19
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (K071832)Medical Scientific, Inc.2007-09-18
SPYGLASS IRRIGATION SYSTEM (K063700)Medical Scientific, Inc.2007-02-08
NEXUS IRRIGATION TUBING SET (K062551)Nexus Medical, LLC2006-12-15
URO PRO (K042457)W.O.M. World of Medicine AG2004-10-25
PIGGYBACK IRRIGATING SYSTEM (K040094)Kosin Technologies, LLC2004-04-15
IRRIGATION SETS (K023808)International Medsurg Connection2003-03-10
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (K010607)Benlan, Inc.2001-11-28
CONTINUOUS FLOW Y-TUBING (K010122)G.U.-Tek2001-06-04
FLO ASSISTANT, MODEL 4-250-00 (K001325)Northgate Technologies, Inc.2000-08-18
MTP UROPUMP DISPOSABLE TUBING SET (K990909)Mtp Medical Technical Promotion GmbH1999-06-09
KSEA UROPUMP (K981615)KARL STORZ Endoscopy-America, Inc.1998-07-08
ENDO FMS UROLOGY (K980808)Future Medical Systems, Inc.1998-05-08
KARL STORZ MODEL 203020 20 EQUIMAT (K971982)KARL STORZ Endoscopy-America, Inc.1997-08-12
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET (K970946)Medline Industries, Inc.1997-06-10
NHMC IRRIGATION TRAY (K962670)National Healthcare Mfg. Corp.1996-08-14
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS (K960787)Baxter Healthcare Corp1996-05-14
NORTHGATE FLOW ASSIST TUBING FOR UROLOGY (K943361)Northgate Technologies, Inc.1995-09-29
AQUISEN (K952583)Aquintel, Inc.1995-08-24
SURGACTIVATOR (K951569)Deschutes Medical Products, Inc.1995-06-06
URO-FLO (K945140)Mallinckrodt Group, Inc.1995-03-08
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP (K945210)KARL STORZ Endoscopy-America, Inc.1995-02-07
THE KARL STORZ UROMAT(TM) (K940983)KARL STORZ Endoscopy-America, Inc.1994-09-20
PRO PULSE SYRINGE IRRIGATION SYSTEM (K941385)Giesy Consultants, Inc.1994-06-09
FILLING VOLUME OPTION (K882295)Eris Medical Technology1988-09-13
STERILE FLUID PRODUCING UNIT #EP550 (K832040)American Cystocope Makers, Inc.1983-09-29
SOLID STATE CONTINUOUS FLOW CONTROL (K822743)Widran Urological Group, Ltd.1982-09-24

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