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
Mar 31, 2016K151832NOVATECH TALCAIR
Novatech SA, FR
GCJ
Mar 1, 2016K160230VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
Covidien
GCJ
Feb 12, 2016K153218Arthrex Synergy UHD4 System
Arthrex, Inc.
GCJ
Feb 1, 2016K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
Carefusion 2200, Inc.
GCJ
Jan 22, 2016K152400General & Plastic Surgery Instruments
Sontec Instruments, Inc.
GCJ
Jan 22, 2016K152149VersaOne Bladed Trocar 5mm
Covidien
GCJ
Dec 15, 2015K1525138X-10-XXXX Camera System
Santa Barbara Imaging Systems
GCJ
Dec 9, 2015K153126da Vinci Xi Hasson Cone
Intuitive Surgical, Inc.
GCJ
Nov 17, 2015K152848AUTOLAP SYSTEM
M.S.T Medical Surgery Technologies, Ltd., IL
GCJ
Nov 6, 2015K151609ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
Nds Surgical Imaging, LLC
GCJ
Oct 26, 2015K151489Retrieval bag system
Beacon Surgical, Inc.
GCJ
Oct 16, 2015K152663Bladeless Optical Obturators
Intuitive Surgical, Inc.
GCJ
Oct 9, 2015K152565Auto Suture Locking Trocar
Covidien
GCJ
Sep 17, 2015K143640KSEA CMOS Camera System (C-cam)
KARL STORZ Endoscopy-America, Inc.
GCJ
Sep 11, 2015K151990Tissue Removal System
Boehringer Laboratories, LLC
GCJ
Sep 4, 2015K151822ab medica irrigation/suction gravity system
Ab Medica Sas, FR
GCJ
Aug 20, 2015K151117Laparoscope Lens Shield Device
Medeon Biodesign, Inc., TW
GCJ
Aug 10, 2015K141594Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
Unimicro Medical Systems (Shenzhen) Co., Ltd., CN
GCJ
Jul 29, 2015K150377Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S
Sony Electronics, Inc.
GCJ
Jul 2, 2015K151548VersaOne Bladed Trocar, VersaOne Bladeless Trocar
Covidien
GCJ
Jun 19, 2015K150781Tissue Removal Pouch
Boehringer Laboratories, LLC
GCJ
Jun 18, 2015K151356Spacemaker Pro Access and Dissector System
Covidien, LLC
GCJ
Jun 10, 2015K150569LaparoVue
Buffalo Filter, LLC
GCJ
Jun 1, 2015K150549Reactor(TM) Trocar and Sleeve
Sharp Medical Prducts, LLC
GCJ
May 26, 2015K141902LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER
Lagis Enterprises Co, Ltd., TW
GCJ
Apr 29, 2015K150633ULTRA Telescopes
Olympus Winter & Ibe GmbH, DE
GCJ
Apr 13, 2015K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical
Minimally Invasive Devices, Inc.
GCJ
Apr 1, 2015K150253Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
Taiwan Surgical Corporation, TW
GCJ
Mar 25, 2015K141715GLOVE PORT
Nelis
GCJ
Mar 5, 2015K142464Entriport
Conmed Corporation
GCJ
Feb 4, 2015K150127Laparoscopic Handles with peek Insulation
Stryker Endoscopy
GCJ
Jan 21, 2015K143299Percuvance(R) Percutaneous Surgical System
Teleflexmedical, Inc.
GCJ
Dec 23, 2014K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
Applied Medical Resources
GCJ
Dec 15, 2014K140593ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
Cook, Inc.
GCJ
Dec 9, 2014K142547Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
Covidien
GCJ
Dec 5, 2014K143221Schoelly Laparoscope
Schoelly Fiberoptic GmbH, DE
GCJ
Nov 26, 2014K143091Surgisleeve Wound Protector
Covidien, LLC
GCJ
Nov 13, 2014K141593UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
Unimicro Medical Systems (Shenzhen) Co., Ltd., CN
GCJ
Nov 12, 2014K142903neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
Neosurgical, Ltd., IE
GCJ
Oct 23, 2014K142603Stryker Precision HD Camera System
Stryker Endoscopy
GCJ
Sep 4, 2014K141272FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR
Minimmally Invasive Devices
GCJ
Aug 4, 2014K141592UNIMICRO SUCTION IRRIATION TUBING SET
Unimicro Medical Systems (Shenzhen) Co., Ltd., CN
GCJ
Jul 10, 2014K140101ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
Ab Medica Sas
GCJ
Jun 12, 2014K132375GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
Genicon
GCJ
Jun 11, 2014K140662FLEX ENDOSCOPIC INSTRUMENTS
Design Standards Corp.
GCJ
Jun 4, 2014K141323VTI SUCTION IRRIGATION SYSTEM
Regulatory Technology Services, LLC
GCJ
May 13, 2014K133272VERSACUT + TISSUE MORCELLATOR
Lumenis, Ltd., IL
GCJ
May 9, 2014K133203SINGLE-SITE PORT
Intuitive Surgical, Inc.
GCJ
Apr 11, 2014K133345REVEEL ENDOSCOPIC RETRACTOR
Retraction Limited, CN
GCJ
Feb 19, 2014K1338458MM TROCAR KIT
Intuitive Surgical
GCJ

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