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
217–240 of 685
Cleared Nov 07, 2001
REPROCESSED ATHROSCOPICS BURS
K012605
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
K012611
Alliance Medical, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCSSED LINVATEC SHAVERS
K012613
Alliance Medical, Inc.
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 Oct 16, 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346
Vanguard Medical Concepts, Inc.
Orthopedic · 84d
Cleared Aug 29, 2001
VULCAN TAC PROBES, MODEL 911XXX
K003198
Oratec Interventions, Inc.
Orthopedic · 321d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Jul 20, 2001
ARTHROSCOPES
K003831
Global Endoscopy, Inc.
Orthopedic · 221d
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 Mar 01, 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
K003893
Oratec Interventions, Inc.
Orthopedic · 73d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Feb 14, 2001
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
K003695
Micro-Medical Devices, Inc.
Orthopedic · 76d
Cleared Feb 14, 2001
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
K010246
Kyphon, Inc.
Orthopedic · 19d
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
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
K002764
Hydrocision, Inc.
Orthopedic · 80d
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