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

Hysteroscope (And Accessories)

Regulation 884.1690

8510(k)s in 12 months (175 all time)
4recalls in 12 months (16 all time)
16recalls that name a 510(k)
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Top companies in HIH

Company510(k)sRecalls
Hologic, Inc.130
KARL STORZ Endoscopy-America, Inc.110
Smith & Nephew, Inc.100
CooperSurgical, Inc.52
Olympus Corporation of the Americas07
Richard Wolf Medical Instruments Corp.61
Interlace Medical, Inc.60
Imagyn Medical, Inc.50
Meditrina, Inc.50
Karl Storz Endoscopy31
Decided510(k)Device and applicantCode
Jul 25, 2018K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pol
Corinth Medtech, Inc.
HIH
Jun 8, 2018K173070HSW Resection Instruments
Henke-Sass, Wolf GmbH, DE
HIH
May 8, 2018K173901MyoSure MANUAL Tissue Removal Device
Hologic, Inc.
HIH
Apr 16, 2018K180096GDT-1000 System
Acuvu, Inc.
HIH
Jan 4, 2018K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units,
Lina Medical Aps, DK
HIH
Sep 20, 2017K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Hologic, Inc.
HIH
Jul 13, 2017K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
CooperSurgical, Inc.
HIH
Nov 22, 2016K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
Smith & Nephew, Inc.
HIH
Jun 14, 2016K160751Symphion Endoscope and Symphion Cervical Sheath
Boston Scientific
HIH
Jun 9, 2016K160510MAKO 7
Nvision Medical Corporation
HIH
Nov 13, 2015K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Hologic, Inc.
HIH
Nov 13, 2015K151275MAKO Device
Nvision Medical
HIH
Sep 2, 2015K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Smith & Nephew, Inc.
HIH
Mar 9, 2015K150158Schoelly Cystoscopes/Hysteroscopes and Accessories
Schoelly Fiberoptic GmbH, DE
HIH
Jan 7, 2015K141515AED HYSTEROSCOPE AND ACCESSORIES
National Advanced Endoscopy Devices, Inc.
HIH
Nov 26, 2014K142029MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Hologic, Inc.
HIH
Jul 2, 2014K132384U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
Endosec Corporation
HIH
Dec 13, 2013K132015TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
Smith & Nephew, Inc.
HIH
Aug 22, 2013K131736MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
Hologic, Inc.
HIH
Aug 22, 2013K131581MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
Hologic, Inc.
HIH
Mar 19, 2013K123330IOGYN ENDOSCOPE
Iogyn, Inc.
HIH
Mar 8, 2013K123151ENDOSEE MODEL 8000 U-SCOPE
Endosee Corp
HIH
Sep 19, 2012K122563MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
Hologic, Inc.
HIH
Sep 10, 2012K122498MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
Hologic, Inc.
HIH
Jul 19, 2012K121868MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
Hologic, Inc.
HIH
Mar 23, 2012K120593MYOSURE CONTROL UNIT
Hologic, Inc.
HIH
Nov 22, 2011K112134TRUCLEAR OPERATIVE HYSTEROSCOPE
Smith & Nephew, Inc.
HIH
Mar 30, 2011K110038TRUCLEAR MORCELLATOR SYSTEM
Smith & Nephew, Inc.
HIH
Mar 25, 2011K103389TRUCLEAR INCISOR PLUS BLADE 2.9
Smith & Nephew, Inc.
HIH
Oct 15, 2010K102686MYOSURE ROD LENS SCOPE SEALS
Interlace Medical, Inc.
HIH
May 18, 2010K093218FEMEYE TWO
Fem Suite, LLC
HIH
Mar 30, 2010K100559MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Interlace Medical, Inc.
HIH
Feb 12, 2010K092421ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
Gimmi GmbH
HIH
Dec 4, 2009K091838OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
Obp Medical
HIH
Oct 23, 2009K091100MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Interlace Medical, Inc.
HIH
Sep 29, 2009K092278GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
Gyrus Acmi, Inc.
HIH
Aug 21, 2009K091465MYOSURE ROD LENS HYSTEROSCOPE
Interlace Medical, Inc.
HIH
Jul 23, 2008K081070INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
Interlace Medical, Inc.
HIH
Apr 17, 2008K073690INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
Interlace Medical, Inc.
HIH
Nov 16, 2007K071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
Vision-Sciences, Inc.
HIH
Mar 31, 2006K053583OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
Optivia Medical, LLC
HIH
Oct 7, 2004K041774IUR RECIPROCATING MORCELLATOR MODEL # 7210517
Smith & Nephew, Inc.
HIH
May 17, 2004K040390STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
Stryker Endoscopy
HIH
Mar 9, 2004K040302VERSAPOINT RESECTOSCOPIC SYSTEM
Gynecare, A Div. of Ethicon, Inc.
HIH
Dec 23, 2003K033113UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
Richard Wolf Medical Instruments Corp.
HIH
Dec 2, 2003K031787SMITH & NEPHEW IUR MORCELLATION SYSTEM
Smith & Nephew, Inc.
HIH
Sep 29, 2003K031974ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
Asap Endoscopic Products GmbH, DE
HIH
Jan 24, 2003K022445VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
Olympus Optical Co., Ltd.
HIH
Aug 22, 2002K022480ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
Acmi Corporation
HIH
Mar 11, 2002K012869GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
Gimmi GmbH, NL
HIH

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