ClearanceBrief
Panels › Gastroenterology, Urology › Product code GCJ · Class 2

Laparoscope, General & Plastic Surgery

Regulation 876.1500

28510(k)s in 12 months (1,431 all time)
2recalls in 12 months (274 all time)
215recalls that name a 510(k)
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Top companies in GCJ

Company510(k)sRecalls
Applied Medical Resources2635
Ethicon Endo-Surgery, Inc.3129
Conmed Corporation847
KARL STORZ Endoscopy-America, Inc.511
Origin Medsystems, Inc.340
Phx Technologies Corp.330
Stryker Endoscopy258
Covidien1318
United States Surgical, A Division of Tyco Healthc300
Richard Wolf Medical Instruments Corp.280
Decided510(k)Device and applicantCode
Aug 27, 1998K973943INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER
Richard Wolf Medical Instruments Corp.
GCJ
Aug 6, 1998K982287ASLAN SENSOR MODULAR INSTRUMENT
Aslan Medical Technologies, Ltd.
GCJ
Aug 6, 1998K981928GALILEO DISPOSABLE ENDOSCOPES
Galileo Electro-Optics Corp.
GCJ
Jul 29, 1998K981941MULTAPORT CANNULA REDUCER AND ACCESSORIES
Dexide, Inc.
GCJ
Jul 17, 1998K973430KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
Eastman Kodak Company
GCJ
Jul 13, 1998K981531SUTURE PLACEMENT DEVICE AND ACCESSORIES
Lsi Solutions
GCJ
Jul 13, 1998K980787HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR
Computer Motion, Inc.
GCJ
Jul 1, 1998K981598HERNIA MESH STABILIZER
Medivices Co.
GCJ
May 29, 1998K981700VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
Origin Medsystems, Inc.
GCJ
May 29, 1998K974771STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
Stryker Endoscopy
GCJ
May 19, 1998K980604SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
Smith & Nephew, Inc.
GCJ
Apr 30, 1998K980623N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
N-Tech Endoscopy, Inc.
GCJ
Apr 28, 1998K980350VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
Cuda Products Co.
GCJ
Apr 24, 1998K980279SONY DXC-LS1 COLOR VIDEO CAMERA
Sony Medical Electronics Co.
GCJ
Apr 21, 1998K974382ACKERMANN SURGICAL INSTRUMENTS
Ackermann Instrumente GmbH
GCJ
Apr 15, 1998K980599NTECH ARTHROSCOPE
N-Tech Endoscopy, Inc.
GCJ
Apr 9, 1998K980079COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
Lumenis, Inc.
GCJ
Mar 31, 1998K973698SCION BALLOON ELEVATOR
Scion International, Inc.
GCJ
Mar 18, 1998K980023ENDOPATH AND PROXIMATE LINEAR CUTTERS
Ethicon Endo-Surgery, Inc.
GCJ
Mar 9, 1998K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
Louisville Laboratories, Inc.
GCJ
Mar 9, 1998K980022ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
Ethicon Endo-Surgery, Inc.
GCJ
Feb 27, 1998K980050MENTOR SKIN PROTECTION PAD
Mentor Corp.
GCJ
Feb 27, 1998K973909KSEA ENDOTIP SYSTEM
KARL STORZ Endoscopy-America, Inc.
GCJ
Feb 24, 1998K973700HERMES OPERATING ROOM CONTROL CENTER
Computer Motion, Inc.
GCJ
Feb 13, 1998K974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
J-Lloyd Medical, Inc.
GCJ
Jan 30, 1998K974391KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
Karl Storz Imaging, Inc.
GCJ
Jan 30, 1998K973814TRUMP-IT II AND MAGNUM 250
Valley West, Inc.
GCJ
Jan 30, 1998K972298ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
The Altomec Corp.
GCJ
Jan 28, 1998K974139LQUET CANNULA/TROCAR SYSTEM
Lifequest Endoscopic Technologies, Inc.
GCJ
Jan 23, 1998K974767SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES
Endoscopy Division
GCJ
Jan 16, 1998K973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK
General Surgical Innovations
GCJ
Jan 12, 1998K974592INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
Smith & Nephew, Inc.
GCJ
Jan 12, 1998K973543KRONNER LOW PROFILE SCOPE HOLDER
Kronner Prototypes, Inc.
GCJ
Jan 9, 1998K970888IOTEC TROCAR AND FLEXIBLE CANNULA
Iotec Industries
GCJ
Jan 8, 1998K974366KSEA PLASTIC TROCARS
Karl Storz Endoscopy
GCJ
Jan 2, 1998K973796S-41 &41S VIDEO IMAGING SYSTEM
Sopro, FR
GCJ
Jan 2, 1998K973795S-52 ELECTRONIC VIDEO LAPAROSCOPE
Sopro, FR
GCJ
Jan 2, 1998K973794S-57 VIDEO IMAGING SYSTEM
Sopro, FR
GCJ
Dec 19, 1997K972699AESOP 3000 SYSTEM AND ACCESSORIES
Computer Motion, Inc.
GCJ
Dec 11, 1997K972280GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
Wilson Greatbatch Technologies, Inc.
GCJ
Dec 9, 1997K973436VISTA HEAD MOUNTED DISPLAY
Vista Medical Technologies, Inc.
GCJ
Dec 2, 1997K973415CURVILINEAR SUTURE PLACEMENT SYSTEM
Laurus Medical Corp.
GCJ
Nov 26, 1997K973249ENDOASSIST
Armstrong Healthcare , Ltd., GB
GCJ
Nov 24, 1997K973359PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
Richard Wolf Medical Instruments Corp.
GCJ
Nov 21, 1997K973232OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
Olympus Winter & Ibe GmbH, DE
GCJ
Nov 13, 1997K973139ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
Ethicon Endo-Surgery, Inc.
GCJ
Nov 7, 1997K973068KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
Karl Storz Endoskop GmbH
GCJ
Nov 6, 1997K972927ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
Richard Wolf Medical Instruments Corp.
GCJ
Oct 29, 1997K972984LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
Lerner Medical, Inc.
GCJ
Oct 24, 1997K972471DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
Smith & Nephew, Inc.
GCJ

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