FQH · Class II · 21 CFR 880.5475

FDA Product Code FQH: Lavage, Jet

Leading manufacturers include Irrimax Corporation, Hydrocision, Inc. and Erbe USA, Inc..

53
Total
53
Cleared
144d
Avg days
1979
Since
53 devices
25–48 of 53
Cleared May 09, 2003
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
K021813
Hydrocision, Inc.
General Hospital · 340d
Cleared Oct 25, 2002
HELIX HYDRO-JET
K022613
Erbe USA, Inc.
General Hospital · 80d
Cleared Oct 10, 2001
HELIX HYDRO-JET
K012464
Andreas Pein Medizintechnik GmbH
General Hospital · 70d
Cleared Jun 22, 2001
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
K011612
Hydrocision, Inc.
General Hospital · 28d
Cleared Mar 31, 2000
HYDROCISION DEBDRIDEMENT SYSTEM
K991383
Hydrocision, Inc.
General Hospital · 345d
Cleared Nov 13, 1998
BLOWER/MISTER
K983135
Cardiothoracic Systems, Inc.
General Hospital · 66d
Cleared Jan 06, 1998
CHASE ANASTOMOSIS VISUALIZATION DEVICE
K974568
Chase Medical, Inc.
General Hospital · 32d
Cleared Dec 16, 1997
FLEXVIEW CO2 BLOWER WITH MIST
K973803
Ethicon Endo-Surgery, Inc.
General Hospital · 71d
Cleared Dec 08, 1997
CLEARVIEW BLOWER/MISTER
K973485
Dlp, Inc.
General Hospital · 84d
Cleared Oct 29, 1997
ARTISAN PULSE LAVAGE SYSTEM
K972551
Howmedica Corp.
General Hospital · 113d
Cleared Jul 29, 1997
STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
K972069
Stryker Instruments
General Hospital · 56d
Cleared Jun 20, 1997
H.V. PULSE LAVAGE (L31 SERIES)
K970916
Global Medical Products, Inc.
General Hospital · 100d
Cleared Sep 19, 1995
STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS
K951666
Stryker Instruments
General Hospital · 162d
Cleared Jul 19, 1994
SIMPULSE SOLO SUCTION IRRIGATOR
K942886
Davol Inc., Sub. C. R. Bard, Inc.
General Hospital · 32d
Cleared Apr 07, 1994
TOP GUN
K933742
Bio-Medical Devices, Inc.
General Hospital · 247d
Cleared Jun 11, 1993
BONE LAVAGE SYSTEM
K926337
Innovative Surgical Devices Corp.
General Hospital · 176d
Cleared Jan 29, 1993
RMI SURGICCAL SITE VISUALIZATION WAND
K922083
Research Medical, Inc.
General Hospital · 270d
Cleared Nov 01, 1991
SURGI-SPRAY O.R. IRRIGATION SYSTEM
K913568
Phoenix Surgical Products, Inc.
General Hospital · 84d
Cleared Dec 30, 1987
PHARMASEAL WOUND IRRIGATION DEVICE
K874022
American Pharmaseal Div. Ahsc
General Hospital · 89d
Cleared Dec 29, 1987
MICRO-AIRE PULSE LAVAGE
K874504
Micro-Aire Surgical Instruments, Inc.
General Hospital · 57d
Cleared Nov 06, 1987
EXCEL PULSED IRRIGATION/SUCTION SYSTEM
K873466
Stryker Corp.
General Hospital · 70d
Cleared May 19, 1986
SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG
K854737
Orthopaedic Devices , Ltd.
General Hospital · 174d
Cleared Jan 27, 1986
PULSE LAVAGE
K854543
Tava Surgical Instruments
General Hospital · 75d
Cleared Mar 29, 1983
DAVOL SURGICAL SUCTION IRRIGATION INSTR
K830386
C.R. Bard, Inc.
General Hospital · 53d