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
169–192 of 683
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 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 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
METRX SYSTEM
K002931
Medtronic Sofamor Danek, Inc.
Orthopedic · 65d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741
Radionics, Inc.
Orthopedic · 137d
Cleared Oct 02, 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437
Endius, Inc.
Orthopedic · 54d
Cleared Sep 19, 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 88d
Cleared Aug 31, 2000
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
K002402
Mitek Products
Orthopedic · 24d
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 May 04, 2000
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
K000691
Oratec Interventions, Inc.
Orthopedic · 65d
Cleared Mar 30, 2000
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046
Richard Wolf Medical Instruments Corp.
Orthopedic · 83d
Cleared Mar 06, 2000
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363
Richard Wolf Medical Instruments Corp.
Orthopedic · 70d