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 Smith & Nephew, Inc..

681
Total
681
Cleared
132d
Avg days
1977
Since
681 devices
73–96 of 681
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 Apr 03, 2002
POWER TEK II
K020761
Biomet, Inc.
Orthopedic · 27d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 78d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Sep 19, 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 88d
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008
United States Surgical, A Division of Tyco Healthc
Orthopedic · 44d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Nov 22, 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 34d
Cleared Jun 01, 1999
KSEA EPIDUROSCOPE
K991051
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 63d
Cleared Nov 25, 1998
DCI ENDOSCOPE
K983384
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 61d
Cleared May 20, 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156
Smith & Nephew, Inc.
Orthopedic · 50d
Cleared Oct 29, 1997
KSEA ARTHROPUMP PLUS
K971649
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 176d
Cleared Aug 12, 1997
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K970511
Smith & Nephew, Inc.
Orthopedic · 182d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Mar 05, 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 57d
Cleared Nov 27, 1996
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
K963029
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 114d
Cleared Oct 10, 1996
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 195d
Cleared May 31, 1996
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
K961713
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 29d
Cleared May 07, 1996
KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
K961244
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 36d
Cleared Apr 10, 1996
ARTHOSCOPE
K960805
United States Surgical, A Division of Tyco Healthc
Orthopedic · 42d