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

DateFirm and productCodeLinked 510(k)
Mar 7, 2022Stryker Corporation
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/s
Open, Classified
GCJK182160
Jun 15, 2021Baxter Healthcare Corporation
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Terminated
GCJK193137
Feb 26, 2021Stryker Corporation
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended u
Terminated
GCJK150956
Feb 8, 2021Sharp Medical Products
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Terminated
GCJK150549
Mar 23, 2020Olympus Corporation of the Americas
Olympus Pleuravideoscope, Model LTF-240
Terminated
GCJK013617
Mar 23, 2020Olympus Corporation of the Americas
Olympus Pleuravideoscope, Model LTF-160
Terminated
GCJK013617
Mar 21, 2019Conmed Corporation
ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer
Terminated
GCJK172940
Mar 21, 2019Conmed Corporation
ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for
Terminated
GCJK172940
Mar 21, 2019Conmed Corporation
ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated intro
Terminated
GCJK172940
Mar 21, 2019Conmed Corporation
ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for
Terminated
GCJK172940
Mar 21, 2019Conmed Corporation
ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for
Terminated
GCJK172940
Mar 21, 2019Conmed Corporation
ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for
Terminated
GCJK172940
Jan 28, 2019Applied Medical Resources Corp
Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in g
Terminated
GCJK041795
K083638
Jun 27, 2018Genicon, Inc.
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Open, Classified
GCJK180579
Jun 20, 2018Espiner Medical Ltd
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automat
Terminated
GCJK111845
Mar 26, 2018Ethicon Endo-Surgery Inc
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Terminated
GCJK032676
Mar 26, 2018Ethicon Endo-Surgery Inc
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Terminated
GCJK032676
Mar 26, 2018Ethicon Endo-Surgery Inc
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Terminated
GCJK032676
Mar 26, 2018Ethicon Endo-Surgery Inc
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
Terminated
GCJK032676
Mar 26, 2018Ethicon Endo-Surgery Inc
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
Terminated
GCJK032676
Nov 17, 2017Stryker Corporation
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposabl
Terminated
GCJK934094
K954726
Jul 19, 2017Genicon, Inc.
GENICON EZEE Retrieval, sterile, Rx only.
Terminated
GCJK162059
Jun 14, 2017Applied Medical Resources Corp
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Terminated
GCJK060096
K072674
May 9, 2017Covidien LLC
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue
Terminated
GCJK931962
May 1, 2017Cook Inc.
LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Terminated
GCJNone listed
May 1, 2017Cook Inc.
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Terminated
GCJNone listed
Mar 8, 2017US Endoscopy Group Inc
Roth Net Polyp Retrieval
Terminated
GCJK122462
Oct 7, 2016Teleflex Medical
Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for
Terminated
GCJK143299
Oct 7, 2016Teleflex Medical
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated fo
Terminated
GCJK143299
Sep 7, 2016Banyan Medical, LLC
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Terminated
GCJK133375
Sep 7, 2016Banyan Medical, LLC
Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
Terminated
GCJK133375
Jul 23, 2016Pentax Medical Company
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue
Terminated
GCJK042741
Jul 22, 2016Carefusion 2200 Inc
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better v
Terminated
GCJK092684
Jun 28, 2016Pentax Medical Company
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems:
Terminated
GCJK042741
Jan 29, 2016Novadaq Technologies Inc.
PINPOINT Endoscopic Fluorescence Imaging System
Terminated
GCJK091515
Sep 16, 2015Lumenis
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and remova
Terminated
GCJK133272
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General &
Terminated
GCJNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General &
Terminated
GCJNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope,
Terminated
GCJNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and
Terminated
GCJNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic
Terminated
GCJNone listed
Jul 24, 2015EXP Pharmaceutical Services Corp
Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Pl
Terminated
GCJNone listed
May 21, 2015DeRoyal Industries Inc
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remo
Terminated
GCJK132375
Dec 19, 2014Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive
Terminated
GCJK141077
Dec 19, 2014Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive
Terminated
GCJK101077
Dec 12, 2014Stryker Endoscopy
1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and captur
Terminated
GCJK132785
Dec 12, 2014Stryker Endoscopy
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture stil
Terminated
GCJK132785
Dec 12, 2014Stryker Endoscopy
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopi
Terminated
GCJK132785
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436
Jun 2, 2014Davol, Inc., Subs. C. R. Bard, Inc.
Bard Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Terminated
GCJK122436

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