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

Decided510(k)Device and applicantCode
Jan 17, 2014K133375BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
Banyan Medical, LLC
GCJ
Dec 16, 2013K132785STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
Stryker Endoscopy
GCJ
Dec 11, 2013K123728RETRIEVAL BAG
Flexbar Machine Corp.
GCJ
Sep 19, 2013K131375AUTOLAP SYSTEM
Mst - Medical Surgery Technologies , Ltd.
GCJ
Aug 22, 2013K132169SURGIQUEST AIRSEAL IFS
Surgiquest, Inc.
GCJ
Aug 1, 2013K130826PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
Stryker Endoscopy
GCJ
Jul 18, 2013K131688NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
Neosurgical, Ltd., IE
GCJ
Jun 7, 2013K131115ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
Nds Surgical Imaging
GCJ
Apr 18, 2013K123280NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
Neosurgical, Ltd., IE
GCJ
Apr 17, 2013K123467VS3
Visionsense, Ltd.
GCJ
Apr 11, 2013K130121SHORT PORT BLUNT TIP TROCAR
Boston Scientific Corporation
GCJ
Mar 14, 2013K130435VERSAPORT V2 BLADELESS OPTICAL TROCAR
Covidien, Formerly US Surgical A Divison of Tyco H
GCJ
Jan 24, 2013K123325Medafor Direct Gas-Assisted Application System
Medafor, Inc.
GCJ
Jan 17, 2013K123110PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
Surgical Innovations Plc, GB
GCJ
Jan 8, 2013K123847MALLEABLE TIP ENDOSCOPIC APPLICATOR
Micromedics, Inc.
GCJ
Jan 3, 2013K123102SOVEREIGN MINI
Aesculap, Inc.
GCJ
Nov 16, 2012K122526360 GAS ASSISTED ENDOSCOPIC APPLICATOR
Micromedics, Inc.
GCJ
Oct 25, 2012K122299SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
Transenterix, Inc.
GCJ
Oct 11, 2012K121796WECK REUSABLE OBTURATOR
Teleflexmedical, Inc.
GCJ
Oct 1, 2012K122511ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
Ethicon Endo-Surgery, LLC
GCJ
Sep 11, 2012K120012INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
Integra LifeSciences Corporation
GCJ
Sep 5, 2012K121893STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
Stryker Endoscopy
GCJ
Aug 10, 2012K120278WIRELESS IMAGE TRANSMITTER UNIT
Olympus Medical Systems Corp.
GCJ
Jul 6, 2012K120468NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
Cook Incorporated
GCJ
Jun 29, 2012K121701SYSTEMS INTEGRATION
Olympus Medical Systems Corp.
GCJ
Jun 28, 2012K120611SONY PVM-2551MD OLED MONITOR
Sony Electronics, Inc.
GCJ
May 30, 2012K112621WIS1000
Foreseeson Custom Displays, Inc.
GCJ
May 25, 2012K121380WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
Teleflexmedical, Inc.
GCJ
Apr 16, 2012K120403SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
Transenterix, Inc.
GCJ
Mar 27, 2012K120061WOUND PROTECTOR
Covidien, Formerly US Surgical A Divison of Tyco H
GCJ
Mar 15, 2012K120608ENDOSCOPIC APPLICATOR
Micromedics, Inc.
GCJ
Mar 9, 2012K112659SURGICAL RETRACTORS
Surgical Innovations Plc, GB
GCJ
Feb 24, 2012K113203SONY LMD-2451MT LCD MONITOR
Sony Electronics, Inc.
GCJ
Oct 17, 2011K112358UNIMAX TROCAR SYSTEM
Unimax Medical Systems, Inc., TW
GCJ
Oct 4, 2011K112456ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
Teleflexmedical, Inc.
GCJ
Sep 26, 2011K111845THE ESPINER SAC OR E SAC
Espiner Medical Limited, GB
GCJ
Sep 1, 2011K112349VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
Covidien, Formerly US Surgical A Divison of Tyco H
GCJ
Jun 6, 2011K101733REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
Sac, LLC Dba Pinnacle Medical Surgical
GCJ
May 19, 2011K103509UNIMAX SUCTION IRRIGATION SET
Unimax Medical Systems, Inc., TW
GCJ
May 10, 2011K110121WEXLER ENDOSCOPE ACCESSORIES
Microsurgical Laboratories,Inc.Dba Wexler Surgical
GCJ
May 6, 2011K110257DIAMOND-FLEX(R) GRASPERS
Carefusion 2200, Inc.
GCJ
May 6, 2011K103510UNIMAX SPECIMEN RETRIEVAL SYSTEM
Unimax Medical Systems, Inc., TW
GCJ
Mar 15, 2011K102839SPIDER STANDARD AND ADVANCED
Transenterix, Inc.
GCJ
Mar 2, 2011K103741SURGISURE TISSUE REMOVAL SYSTEM
Interlace Medical, Inc.
GCJ
Feb 24, 2011K103253SILS PORT
Coviden (Formerly Registered AS US Surgical, A Div
GCJ
Feb 8, 2011K100533VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
Vibrynt, Inc.
GCJ
Feb 4, 2011K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
Intuitive Surgical, Inc.
GCJ
Jan 5, 2011K102379LTF-Y0009; MAJ-YOO41; XOEV-3D1
Olympus Medical Systems Corporation
GCJ
Nov 3, 2010K102646SPIDER FLEX MONOPOLAR HOOK
Transenterix, Inc.
GCJ
Oct 18, 2010K101193PMC LAPAROSCOPIC INSTRUMENTS
Pmc Medical GmbH, DE
GCJ

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