Atlas FDA

KDH

23 FDA 510(k) clearances · Product code

93 daysmedian time to decision
214 days90th percentile
23clearances measured

FDA profile

Official device name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 5 · 2002: 4 · 2003: 4 · 2004: 4 · 2007: 2 · 2017: 10
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
GILTECH PLUS CONNECTING TUBE SET (K983624)Giltech Plus, Inc.1999-03-18
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (K981286)Armm, Inc.1998-06-19
COMBIPORT FLUID LAVAGE DEVICE (K971259)B.Braun Medical, Inc.1997-10-27
TUM-E-VAC (K962850)Ethox Corp.1997-02-21
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (K951533)Ballard Medical Products1995-07-05
FLUSHING IRRIGATION SET (K923497)Orion Life Systems, Inc.1994-03-21
TRI-MED GASTRIC LAVAGE SYSTEM (K920619)Tri-Med Specialties, Inc.1992-09-04
TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (K920527)Tri-Med Specialties, Inc.1992-09-04
QUICVAGE PLUS (K914908)Autovage1992-04-13
QUICVAGE (K914907)Autovage1992-01-24
ECONOVAGE R (K911788)Autovage1991-07-26
MINIVAGE(R) (K911919)Autovage1991-07-26
IRRIGATION/ASPIRATION TUBING SET (K911324)Biomedical Dynamics, Inc.1991-06-24
STOMACH, GASTRO-ENTEROSTOMY (K902421)Gainor Medical Europe, Ltd.1990-11-20
HEMORRHOIDAL LIGATOR WITH SUCTION (K900086)Baxter Healthcare Corp1990-03-19
EASI-LAV ADULT GASTRIC LAVAGE KIT (K896573)Clairson Industries, LLC1990-01-29
LEONARD TUBE (K892334)Surgidyne, Inc.1989-05-31
ETHOX LAVAGE TUBE (K860599)Ethox Corp.1986-03-11
DISPOSABLE IRRIGA/ASPIR. SYSTEM (K821496)Innovative Surgical Products, Inc.1982-06-22
TUBING, AXIOM SILICONE PENROSE (K781749)Axiom Medical, Inc.1978-12-04
THERAPEUTIC APPARATUS, DIERKER TYPE (K770534)Well Being Ent.1978-04-21
ARGYLE RAPID GASTRIC LAVAGE KIT (K770248)Sherwood Medical Industries1977-03-09
IRRIGATION CATHETER (K760556)Sherwood Medical Industries1977-02-17

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