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..

683
Total
683
Cleared
132d
Avg days
1977
Since
683 devices
241–264 of 683
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared May 21, 1997
TENOSCOPE
K970642
Luxtec Corp.
Orthopedic · 90d
Cleared May 14, 1997
TENOSNARE
K970562
Luxtec Corp.
Orthopedic · 90d
Cleared Mar 05, 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 57d
Cleared Mar 04, 1997
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
K964879
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 89d
Cleared Feb 24, 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975
Cohort Medical Products Group, Inc.
Orthopedic · 74d
Cleared Jan 28, 1997
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
K964919
Emerald Medical, Inc.
Orthopedic · 50d
Cleared Jan 22, 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304
Stryker Endoscopy
Orthopedic · 153d
Cleared Jan 17, 1997
HSW GMBH ARTHROSCOPE
K962075
Henke Sass Wolf of America, Inc.
Orthopedic · 234d
Cleared Dec 20, 1996
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
K964215
Smith & Nephew Endoscopy, Inc.
Orthopedic · 59d
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 Sep 11, 1996
AMO ARTHOSCOPES
K962330
American Microptiks, Inc.
Orthopedic · 86d
Cleared Sep 04, 1996
MYELOTEC MYELOSCOPE
K960194
Myelotec, Inc.
Orthopedic · 232d
Cleared Aug 22, 1996
ARTHRO-SURGIMAT
K962114
W.O.M. World of Medicine GmbH
Orthopedic · 83d
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