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GBX

77 FDA 510(k) clearances · Product code

83 daysmedian time to decision
254 days90th percentile
77clearances measured

FDA profile

Official device name
Catheter, Irrigation
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 383 · 2022: 477 · 2023: 628 · 2024: 945 · 2025: 1,193 · 2026: 715
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
MOERAE VEIN PREPARATION KIT (K131659)Moerae Matrix, Inc.2014-03-03
GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725)Maquet Cardiovascular, LLC2008-12-17
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (K052286)The Catheter Exchange, Inc.2005-10-21
GRAFTSAVER (K043515)Vescare, Inc.2005-03-31
MISONIX IRRIGATION SYSTEM MOEDL BC20P (K013417)Misonix, Inc.2002-01-10
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704)Dmc Medical, Ltd.2000-05-19
LYSONIX IRRIGATION SYSTEM (K974233)Lysonix, Inc.1998-02-03
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703)Allegiance Healthcare Corp.1997-12-04
ULTRACELL SUCTION SPONGE (K972635)Ultracell Medical Technologies, Inc.1997-10-01
FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146)Axiom Medical, Inc.1997-03-10
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295)Sil-Med Corp.1996-06-26
CLOSED FLUID COLLECTION SYSTEM (K961147)B.Braun Medical, Inc.1996-05-31
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING (K960955)Baxter Healthcare Corp1996-05-22
HYDROLOGY 5000 (K955339)Northgate Technologies, Inc.1996-03-13
NEO-PNEUMOCATH (K955474)Intra Special Catheters GmbH1996-02-13
OPTI-DRAIN MULTI-USE DRAINAGE CATHETER (K955505)Navarre Biomedical , Ltd.1996-02-07
THE REEL THING (MODIFICATION) (K955439)Biomedical Devices, Inc.1995-12-26
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (K926496)Sil-Med Corp.1995-05-24
NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (K951907)Navarre Biomedical , Ltd.1995-05-15
NAVARRE UNIVERSAL DRAINAGE CATHETER (K951475)Navarre Biomedical , Ltd.1995-04-24
ANGIOCATH SIDEHOLDER DRAINAGE CATHETER (K950437)Becton Dickinson Vascular Access, Inc.1995-03-14
INSYTE SIDEHOLDED DRAINAGE CATHETER (K950439)Becton Dickinson Vascular Access, Inc.1995-03-14
ACI SILICATH THORACIC CATHETER (K942335)American Catheter1994-08-09
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (K925243)Deknatel, Inc.1994-07-27
THE REEL THING (K940156)Bio-Medical Devices, Inc.1994-06-07
ORION SUCTION CATHETER KIT WITH STERILE SALINE (K942274)Regulatory & Marketing Services, Inc.1994-06-02
ORION SUCTION CATHETER KIT WITH STERILE WATER (K942273)Regulatory & Marketing Services, Inc.1994-06-02
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (K935531)Puritas Health Care, Inc.1994-05-05
STORZ N5941 SERIES MEDICAL GRADE TUBING (K940352)Storz Instrument Co.1994-04-14
NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS (K933600)Navarre Biomedical , Ltd.1994-03-28
SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (K926495)Sil-Med Corp.1994-02-02
SIL-SLIP FLAT SUCTION DRAIN (K926408)Sil-Med Corp.1994-02-02
NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET (K932391)Navarre Biomedical , Ltd.1994-01-27
ERCP CATHETER, HYDROPHILIC COATED (K932205)Wilson-Cook Medical, Inc.1994-01-03
URESIL ABSCESS DRIANAGE AND IRRIGATION SET (K925117)Uresil Corp.1993-08-11
FLUID DRAINAGE TRAY (K926109)Symbiosis Corp.1993-06-07
KENDALL UNIVERSAL EXTENSION SET (K930551)Kendall Healthcare Products Co. Div.Of Tyco Health1993-05-12
IRRIGATION/SUCTION PROBE (K923667)Surgical Instrument, Inc.1993-04-23
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE (K925176)Boston Scientific Corp1993-04-08
KENDALL WOUND DRAINAGE SYSTEMS-TROCARS (K925805)Kendall Healthcare Products Co. Div.Of Tyco Health1993-02-26
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN (K925748)Kendall Healthcare Products Co. Div.Of Tyco Health1993-01-13
TURKEL ABDOMINAL PARACENTESIS SYSTEM (K924702)Symbiosis Corp.1993-01-12
ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET (K925533)Angeion Corp.1993-01-12
SIL-MED FLAT SUCTION DRAIN (K921424)Sil-Med Corp.1992-09-28
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE (K922739)Hollister, Inc.1992-08-06
INTRADUCER (K921934)Taut, Inc.1992-07-15
PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT (K921095)Pacer Tool & Plastics, Inc.1992-04-29
THORACIC CATHETER WITH GUIDE (K913542)Intl. Medical Devices , Ltd.1992-01-21
THORACIC CATHTER STYLET (K913539)Intl. Medical Devices , Ltd.1992-01-21
I/A HANDPIECE WITH REPLACEABLE TIPS (K910245)Surgical Technologies, Inc.1991-04-22
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS (K905614)Baxter Healthcare Corp1991-03-20
DRAINAGE TUBE RESTRAINT/WOUND COVER (K905766)M. Imonti and Associates Inc.,1991-03-06
PVC ROUND WOUND DRAINS (K905422)Axiom Medical, Inc.1991-02-11
DISPOSABLE FLUID COLLECTION BAG (K904133)Axiom Medical, Inc.1990-10-11
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 (K895516)Arrow Intl., Inc.1989-12-27
MIKRO-AQUAPURATOR (K895756)Mikro-Tek Laboratories1989-12-27
MIKRO-LAVAGE-1 (K895755)Mikro-Tek Laboratories1989-12-27
IRRI-EVACUATOR (K895757)Mikro-Tek Laboratories1989-10-19
THORACIC CATHETERS (K883474)Westmark, Sterile Packing Systems, Inc. (Sps)1988-09-13
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET (K870704)American Pharmaseal Div. Ahsc1987-03-27
CONTINUOUS VENTILATOR (K844809)Hamilton Medical, Inc.1985-06-27
HALL IRRIGATION SYSTEM (K852143)Hall Surgical, Division of Zimmer, Inc.1985-06-26
PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, (K844876)Pennine Medical , Ltd.1985-06-05
MICROTEK IRRIGATION SYSTEM (K844061)Microtek Medical, Inc.1985-05-21
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 (K851475)Vygon Corp.1985-05-03
PERIMETER THORACIC CATHETER (K844922)Perimeter Medical, Inc.1985-03-18
PRUITT IRRIGATION AND OCCLUSION CATHETER (K844094)Bionomy, Inc.1984-11-29
SDC SILICONE SUMP DRAIN (K843617)Science Development Corp.1984-10-24
TIDAL DISTENSION IRRIGATION SET (K841362)Abbott Laboratories1984-08-02
SILICONE SUCTION & IRRIGATION DRAIN (K840323)Superior Plastic Products Corp.1984-04-25
I/A KIT (K830859)Surgeon Surgical Instrumentation, Inc.1983-05-02
ARTHROSCOPIC IRRIGATION SETS-2C4030/31 (K823496)Travenol Laboratories, S.A.1982-12-28
SUCTION CATHETER W/STERILE WATER (K822510)Medine Dynacor1982-10-13
IRRIGATION CATHETER (K780788)Shiley, Inc.1978-06-22
CURITY IRRIGATION TRAY (K771079)Kendall Research Center1977-09-15
CATHETER, IRRIGATION (K770706)Mallinckrodt Critical Care1977-05-06
SUMP DRAIN, W/FILTER, ARGYLE EDLICH (K770442)Sherwood Medical Industries1977-03-30

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