HRX · Class II · 21 CFR 888.1100

FDA Product Code HRX: Arthroscope

FDA product code HRX covers arthroscopes used for direct visualization of joint interiors during arthroscopic surgery.

These rigid optical instruments are inserted through small portals into the joint to visualize cartilage, ligaments, and synovial tissue during diagnostic and therapeutic arthroscopic procedures. They are used in knee, shoulder, hip, ankle, and wrist arthroscopy.

HRX devices are Class II medical devices, regulated under 21 CFR 888.1100 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Arthrex, Inc. and Acufex Microsurgical, Inc..

681
Total
681
Cleared
132d
Avg days
1977
Since
681 devices
97–120 of 681
Cleared Apr 02, 2003
KSEA POWERSHAVER SYSTEM S2
K030009
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Mar 20, 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 18, 2003
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
K030096
Arthrex, Inc.
Orthopedic · 67d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 13, 2003
DAVOL ARTHROVENT OUTFLOW TUBING
K030307
Davol, Inc.
Orthopedic · 15d
Cleared Dec 02, 2002
KSEA SPINOSCOPE
K023187
Karl Storz Endoscopy
Orthopedic · 69d
Cleared Apr 03, 2002
POWER TEK II
K020761
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 29, 2001
RESECTION ABLATOR
K013117
Linvatec Corp.
Orthopedic · 72d
Cleared Nov 08, 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652
Alliance Medical Corp.
Orthopedic · 87d
Cleared Nov 07, 2001
REPROCESSED ATHROSCOPICS BURS
K012605
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 02, 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536
Sterilmed, Inc.
Orthopedic · 87d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Jun 28, 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
K011083
Arthrocare Corp.
Orthopedic · 79d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 78d
Cleared May 30, 2001
PERC-D SPINEWAND
K010811
Arthrocare Corp.
Orthopedic · 72d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677
Medtronic Xomed, Inc.
Orthopedic · 61d
Cleared Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740
Aesculap, Inc.
Orthopedic · 144d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088
Linvatec Corp.
Orthopedic · 238d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Feb 09, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179
Ebi, L.P.
Orthopedic · 21d
Cleared Jan 04, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898
Ebi, L.P.
Orthopedic · 17d
Cleared Nov 24, 2000
METRX SYSTEM
K002931
Medtronic Sofamor Danek, Inc.
Orthopedic · 65d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741
Radionics, Inc.
Orthopedic · 137d