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..

685
Total
685
Cleared
132d
Avg days
1977
Since
685 devices
289–312 of 685
Cleared Jan 30, 1998
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
K973499
Xomed, Inc.
Orthopedic · 136d
Cleared Nov 21, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
K971781
Wilson Greatbatch Technologies, Inc.
Orthopedic · 191d
Cleared Oct 29, 1997
KSEA ARTHROPUMP PLUS
K971649
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 176d
Cleared Oct 24, 1997
TOTAL PERFORMANCE SYSTEM SHAVER
K973195
Stryker Endoscopy
Orthopedic · 59d
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 Jul 31, 1997
MEDIVISION ARTHROSCOP
K971996
Medivision Scope Service Center, Inc.
Orthopedic · 62d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jun 23, 1997
ARTHROSCOPE
K971083
Electro-Biology, Inc.
Orthopedic · 90d
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 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