FDA 510(k) Applications for Medical Device Product Code "HEW"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K143308 | APPLIED MEDICAL RESOURCES | GelPOINT Transvaginal Access Platform | 10/13/2015 |
K191294 | Applied Medical Resources Corp. | Transvaginal Access Platform | 09/06/2019 |
K980972 | CIRCON CORP. | RIGID CULDOSCOPE AND ACCESSORIES | 06/12/1998 |
K143650 | Cooper Surgical Inc. | CooperSurgical Advincula Delineator Uterine Manipulator | 07/21/2015 |
K180429 | CooperSurgical, Inc. | Advincula Delineator Uterine Manipulator | 03/14/2018 |
K201086 | CooperSurgical, Inc. | Advincula Delineator Uterine Manipulator | 05/21/2020 |
K954311 | COOPERSURGICAL, INC. | KOH COLPOTOMIZER SYSTEM | 11/19/1996 |
K051594 | GYNETECH PTY. LTD. | MCCARTNEY ACCESS TUBE | 09/02/2005 |
K051160 | INSITU SYSTEMS | MANIPUSEAL | 09/02/2005 |
K110819 | J.SINGH INSTRUMENTS | SINGHMED ROOLIP MANIPULATOR | 10/05/2011 |
K962881 | KARL STORZ ENDOSCOPY | KSEA CULDOCENTESIS SET | 10/22/1996 |
K993804 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA RIGID CULDOSCOPE AND ACCESSORIES | 02/07/2000 |
K033728 | KARL STORZ ENDOSCOPY-AMERICA, INC. | TRANSVAGINAL ENDOSCOPY SET | 02/27/2004 |
K111014 | LSI SOLUTIONS, INC. | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | 07/13/2012 |
K964276 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | 11/25/1997 |
K992655 | SOPRANE S.A. | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | 03/13/2000 |
K161065 | Surgitools Pty Ltd. | ColpoWaveÖ Colpotomizer and CerviGripÖ Uterine Manipulator | 10/27/2016 |