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
145–168 of 681
Cleared Sep 25, 1997
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
K972768
Blackstone Medical, Inc.
Orthopedic · 63d
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 18, 1997
UNIVERSAL DRIVE SYSTEM
K971059
Linvatec Corp.
Orthopedic · 86d
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 Jan 22, 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304
Stryker Endoscopy
Orthopedic · 153d
Cleared Nov 27, 1996
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
K963029
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 114d
Cleared Nov 14, 1996
KSEA LARGE JOINT ARTHROSCOPY SET
K963524
Karl Storz Endoscopy
Orthopedic · 71d
Cleared Oct 11, 1996
THERMO-PLASTIC SHAVER BLADES
K963332
Stryker Endoscopy
Orthopedic · 49d
Cleared Oct 10, 1996
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 195d
Cleared Oct 08, 1996
APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
K961590
Linvatec Corp.
Orthopedic · 167d
Cleared Jul 19, 1996
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K962321
Arthrocare Corp.
Orthopedic · 32d
Cleared Jul 15, 1996
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
K961747
Arthrocare Corp.
Orthopedic · 70d
Cleared Jun 21, 1996
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
K961853
Acufex Microsurgical, Inc.
General & Plastic Surgery · 38d
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
Cleared Mar 08, 1996
PERCUTANEOUS ENDOSCOPIC DISCECTOMY
K960222
Richard Wolf Medical Instruments Corp.
Orthopedic · 52d
Cleared Feb 14, 1996
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
K954652
Aesculap, Inc.
Orthopedic · 127d
Cleared Feb 09, 1996
BOZOTTA REINSERTION FORCEPS
K955480
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 71d
Cleared Jan 17, 1996
KARL STORZ TARGETING UNIT
K955652
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 36d
Cleared Dec 18, 1995
INCL ENDOSCOPE
K955471
Sofamor Danek USA,Inc.
Orthopedic · 69d
Cleared Dec 08, 1995
CANNULOC THREADED CANNULA
K955273
Linvatec Corp.
Orthopedic · 23d