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Panels › Obstetrics/Gynecology › Product code HET · Class 2

Laparoscope, Gynecologic (And Accessories)

Regulation 884.1720

0510(k)s in 12 months (338 all time)
0recalls in 12 months (19 all time)
16recalls that name a 510(k)
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Top companies in HET

Company510(k)sRecalls
KARL STORZ Endoscopy-America, Inc.290
Dixon Medical, Inc.120
ETHICON, Inc.111
Applied Medical Resources74
Marlo Surgical Technology100
Baxter Healthcare Corp90
Kli90
Richard Wolf Medical Instruments Corp.90
United States Surgical, A Division of Tyco Healthc90
Olympus America, Inc.80
DateFirm and productCodeLinked 510(k)
Apr 3, 2024Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Open, Classified		 HETK951343
Jan 10, 2024Olympus Corporation of the Americas
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and
Open, Classified		 HETK190744
Jan 5, 2024Olympus Corporation of the Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical uni
Open, Classified		 HETK111425
Jan 5, 2024Olympus Corporation of the Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical un
Open, Classified		 HETK201832
Dec 18, 2023Karl Storz Endoscopy
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Open, Classified		 HETK951190
Feb 23, 2022Carefusion 2200 Inc
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 c
Terminated		 HETK982276
Feb 21, 2017Olympus Corporation of the Americas
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W710
Terminated		 HETK111788
Dec 10, 2015Olympus Corporation of the Americas
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes
Terminated		 HETK111788
Aug 2, 2014Market-Tiers Inc
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, s
Terminated		 HETK091010
Nov 10, 2009Ethicon, Inc.
Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876
Terminated		 HETK061050
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Terminated		 HETK012884
K945741
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Terminated		 HETK012884
K945741
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Terminated		 HETK012884
K945741
Oct 7, 2008Applied Medical Resources Corp
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Terminated		 HETK012884
K945741
Jun 27, 2006Stryker Endoscopy
Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
Terminated		 HETK943508
Jul 20, 2004Guidant Cardiac Surgery
Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
Terminated		 HETK020143
Dec 17, 2003Ethicon Endo-Surgery
FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.
Terminated		 HETNone listed
Dec 17, 2003Ethicon Endo-Surgery
FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063.
Terminated		 HETNone listed
Dec 17, 2003Ethicon Endo-Surgery
FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065.
Terminated		 HETNone listed

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